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Clinical Trial Results:
A Phase 1/2a Study of BMS-986205 Administered in Combination with Nivolumab (anti-PD-1 Monoclonal Antibody) and in Combination with Both Nivolumab and Ipilimumab (anti-CTLA-4 Monoclonal Antibody) in Advanced Malignant Tumors

Summary
EudraCT number	2015-004914-79
Trial protocol	ES   PL   NO   FI   SE   IT
Global end of trial date	26 Oct 2021
Results information
Results version number	v2(current)
This version publication date	23 Jul 2023
First version publication date	15 Dec 2022
Other versions	v1
Version creation reason

Trial information Top of page
Trial identification
Sponsor protocol code	CA017-003
Additional study identifiers
ISRCTN number	-
US NCT number	NCT02658890
WHO universal trial number (UTN)	-
Sponsors
Sponsor organisation name	Bristol-Myers Squibb
Sponsor organisation address	Chaussée de la Hulpe 185, Brussels, Belgium, 1170
Public contact	EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com
Scientific contact	Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com
Paediatric regulatory details
Is trial part of an agreed paediatric investigation plan (PIP)	No
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?	No
Results analysis stage
Analysis stage	Final
Date of interim/final analysis	14 Mar 2022
Is this the analysis of the primary completion data?	No
Global end of trial reached?	Yes
Global end of trial date	26 Oct 2021
Was the trial ended prematurely?	No
General information about the trial
Main objective of the trial	To assess the safety, tolerability, dose limiting toxicities (DLTs), and maximum tolerated dose (MTD)/maximum administered dose (MAD)/alternate dose(s), anti-tumor activity, pharmacodynamics, and pharmacokinetics of BMS-986205 (IDO) administered as monotherapy and in combination with nivolumab (Nivo) or Nivo and Ipilimumab (Ipi) in subjects with advanced malignant tumors.
Protection of trial subjects	The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.
Background therapy	-
Evidence for comparator	-
Actual start date of recruitment	22 Feb 2016
Long term follow-up planned	No
Independent data monitoring committee (IDMC) involvement?	No
Population of trial subjects
Number of subjects enrolled per country
Country: Number of subjects enrolled	Australia: 104
Country: Number of subjects enrolled	Canada: 107
Country: Number of subjects enrolled	Germany: 6
Country: Number of subjects enrolled	Spain: 94
Country: Number of subjects enrolled	Finland: 7
Country: Number of subjects enrolled	France: 119
Country: Number of subjects enrolled	Italy: 18
Country: Number of subjects enrolled	Norway: 3
Country: Number of subjects enrolled	Poland: 18
Country: Number of subjects enrolled	United States: 151
Worldwide total number of subjects	627
EEA total number of subjects	265
Number of subjects enrolled per age group
In utero	0
Preterm newborn - gestational age < 37 wk	0
Newborns (0-27 days)	0
Infants and toddlers (28 days-23 months)	0
Children (2-11 years)	0
Adolescents (12-17 years)	0
Adults (18-64 years)	372
From 65 to 84 years	252
85 years and over	3

Trial information Top of page

Subject disposition Top of page
Recruitment
Recruitment details	-
Pre-assignment
Screening details	626 participants were treated. Participants enrolled in the QTc Substudy and Food Effect/ Relative BA (FE BA) Substudy are separate participants from the Part 1 Dose Escalation phase.
Period 1
Period 1 title	Pre-Treatment Phase
Is this the baseline period?	Yes
Allocation method	Non-randomised - controlled
Blinding used	Not blinded
Arms
Are arms mutually exclusive	Yes
Arm title	Part 1: BMS25+NIV240(ESC)
Arm description	BMS-986205 25mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	25 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 1: BMS50+NIV240(ESC)
Arm description	BMS-986205 50mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	50 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 1: BMS100+NIV240(ESC)
Arm description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 1: BMS200+NIV240(ESC)
Arm description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	200 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 1: BMS400+NIV240(ESC)
Arm description	BMS-986205 400mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	400 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp Cervical + (IDO 100)
Arm description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp Cervical + (IDO 200)
Arm description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	200 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp Pancreatic
Arm description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp DLBCL
Arm description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp SCCHN + (IDO 100)
Arm description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp SCCHN + (IDO 200)
Arm description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	200 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp Bladder + (IDO 100)
Arm description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp Bladder + (IDO 200)
Arm description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	200 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp ML I-O Naive
Arm description	BMS-986205 100mg+ nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp ML BRAF-MT
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp ML BRAF-MT- NIVO
Arm description	Nivolumab 480mg administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Arm title	Part 2: Exp ML Anti-PDL1
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp ML Anti-PDL1+CTLA4
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp NSCLC I-O Naive
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp NSCLC Anti-PDL1
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Arm title	Part 2: Exp ASST
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp Renal
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Arm title	Part 3: Melanoma and NSCLC
Arm description	BMS-986205 + nivolumab + ipilimumab triple therapy. BMS-986205 administered orally in tablet or capsule formulation. Nivolumab and ipilimumab administered as IV infusion.
Arm type	Experimental
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	50 mg was administered orally in tablet or capsule formulation daily
Investigational medicinal product name	Ipilimumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	1 mg/kg was administered as an IV infusion once every 8 weeks (Melanoma)) once every 6 weeks (NSCLC)
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks (Melanoma) and 360 mg was administered as an IV infusion once every 3 weeks (NSCLC)
Arm title	Unplanned - BMS50
Arm description	BMS-986205 50mg administered orally in tablet or capsule formulation.
Arm type	Experimental
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	50 mg was administered orally in tablet or capsule formulation
Arm title	QTc Substudy
Arm description	BMS-986205 + nivolumab combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	50 mg, 100 mg, or 200 mg was administered orally in tablet or capsule formulation daily
Arm title	Food Effect/ Relative BA (FE BA) Substudy
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Unplanned
Arm description	Nivolumab 480mg administered as IV infusion.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion
Number of subjects in period 1 Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 2: Exp Pancreatic Part 2: Exp DLBCL Part 2: Exp SCCHN + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp Bladder + (IDO 200) Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp NSCLC I-O Naive Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp ASST Part 2: Exp Renal Part 3: Melanoma and NSCLC Unplanned - BMS50 QTc Substudy Food Effect/ Relative BA (FE BA) Substudy Unplanned Started 7 11 12 18 7 18 17 22 36 15 14 14 16 79 9 6 37 17 80 41 32 42 41 1 20 14 1 Completed 7 11 12 18 7 18 17 22 35 15 14 14 16 79 9 6 37 17 80 41 32 42 41 1 20 14 1 Not completed 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0      Participant No Longer Meets Study Criteria - - - - - - - - 1 - - - - - - - - - - - - - - - - - -
Period 2
Period 2 title	Treatment Phase
Is this the baseline period?	No
Allocation method	Non-randomised - controlled
Blinding used	Not blinded
Arms
Are arms mutually exclusive	Yes
Arm title	Part 1: BMS25+NIV240(ESC)
Arm description	BMS-986205 25mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	25 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 1: BMS50+NIV240(ESC)
Arm description	BMS-986205 50mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	50 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 1: BMS100+NIV240(ESC)
Arm description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 1: BMS200+NIV240(ESC)
Arm description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	200 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 1: BMS400+NIV240(ESC)
Arm description	BMS-986205 400mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	400 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp Cervical + (IDO 100)
Arm description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp Cervical + (IDO 200)
Arm description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	200 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp Pancreatic
Arm description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp DLBCL
Arm description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp SCCHN + (IDO 100)
Arm description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Arm title	Part 2: Exp SCCHN + (IDO 200)
Arm description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	200 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp Bladder + (IDO 100)
Arm description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp Bladder + (IDO 200)
Arm description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	240 mg was administered as an IV infusion once every 2 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	200 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp ML I-O Naive
Arm description	BMS-986205 100mg+ nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp ML BRAF-MT
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp ML BRAF-MT- NIVO
Arm description	Nivolumab 480mg administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Arm title	Part 2: Exp ML Anti-PDL1
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp ML Anti-PDL1+CTLA4
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp NSCLC I-O Naive
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Part 2: Exp NSCLC Anti-PDL1
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Arm title	Part 2: Exp ASST
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Arm title	Part 2: Exp Renal
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Arm type	Experimental
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks
Arm title	Part 3: Melanoma and NSCLC
Arm description	BMS-986205 + nivolumab + ipilimumab triple therapy. BMS-986205 administered orally in tablet or capsule formulation. Nivolumab and ipilimumab administered as IV infusion.
Arm type	Experimental
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	50 mg was administered orally in tablet or capsule formulation daily
Investigational medicinal product name	Ipilimumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	1 mg/kg was administered as an IV infusion once every 8 weeks (Melanoma)) once every 6 weeks (NSCLC)
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion once every 4 weeks (Melanoma) and 360 mg was administered as an IV infusion once every 3 weeks (NSCLC)
Arm title	Unplanned - BMS50
Arm description	BMS-986205 50mg administered orally in tablet or capsule formulation.
Arm type	Experimental
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	50 mg was administered orally in tablet or capsule formulation
Arm title	QTc Substudy
Arm description	BMS-986205 + nivolumab combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	50 mg, 100 mg, or 200 mg was administered orally in tablet or capsule formulation daily
Arm title	Food Effect/ Relative BA (FE BA) Substudy
Arm description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion
Investigational medicinal product name	BMS-986205
Investigational medicinal product code
Other name
Pharmaceutical forms	Capsule
Routes of administration	Oral use
Dosage and administration details	100 mg was administered orally in tablet or capsule formulation daily
Arm title	Unplanned
Arm description	Nivolumab 480mg administered as IV infusion.
Arm type	Experimental
Investigational medicinal product name	Nivolumab
Investigational medicinal product code
Other name
Pharmaceutical forms	Solution for injection
Routes of administration	Intravenous use
Dosage and administration details	480 mg was administered as an IV infusion
Number of subjects in period 2 Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 2: Exp Pancreatic Part 2: Exp DLBCL Part 2: Exp SCCHN + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp Bladder + (IDO 200) Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp NSCLC I-O Naive Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp ASST Part 2: Exp Renal Part 3: Melanoma and NSCLC Unplanned - BMS50 QTc Substudy Food Effect/ Relative BA (FE BA) Substudy Unplanned Started 7 11 12 18 7 18 17 22 35 15 14 14 16 79 9 6 37 17 80 41 32 42 41 1 20 14 1 Completed 1 2 1 3 0 0 2 1 4 3 3 4 4 31 3 3 3 3 18 2 8 8 9 0 2 1 0 Not completed 6 9 11 15 7 18 15 21 31 12 11 10 12 48 6 3 34 14 62 39 24 34 32 1 18 13 1      Adverse event, serious fatal - - - - - - - - - - - - - - - - - - 1 - - - - - - - -      Consent withdrawn by subject - 1 - - - - 1 - - 1 - - 1 3 - - 1 - 4 3 - 4 1 1 - - -      Participant No Longer Meets Study Criteria - - - 1 - - - - - 1 - - - - - - - - 1 - - - 1 - - - -      Adverse event, non-fatal - 1 2 2 1 - - 2 1 2 3 - 1 4 - - - - 5 1 3 - 5 - 2 1 -      Other Reasons - - - - - - 1 - 1 - - - - 2 - - - - 1 - - - - - - 1 1      Non-compliance With Study Drug - - 1 - - - - - - - - - - - - - - - 1 - - - - - - - -      Progressive Disease 6 7 6 12 6 18 12 19 26 8 7 9 8 29 6 2 32 14 40 32 19 30 15 - 14 11 -      Maximum Clinical Benefit - - - - - - - - - - - - - 1 - - - - 1 - - - 2 - - - -      Study Drug Toxicity - - 2 - - - - - 3 - 1 1 2 9 - 1 1 - 8 3 2 - 8 - 2 - -      Lost to follow-up - - - - - - 1 - - - - - - - - - - - - - - - - - - - -

Subject disposition Top of page

Baseline characteristics Top of page
Baseline characteristics reporting groups
Reporting group title	Part 1: BMS25+NIV240(ESC)
Reporting group description	BMS-986205 25mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS50+NIV240(ESC)
Reporting group description	BMS-986205 50mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS100+NIV240(ESC)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS200+NIV240(ESC)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS400+NIV240(ESC)
Reporting group description	BMS-986205 400mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Cervical + (IDO 100)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Cervical + (IDO 200)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Pancreatic
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp DLBCL
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp SCCHN + (IDO 100)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp SCCHN + (IDO 200)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Bladder + (IDO 100)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Bladder + (IDO 200)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp ML I-O Naive
Reporting group description	BMS-986205 100mg+ nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML BRAF-MT
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML BRAF-MT- NIVO
Reporting group description	Nivolumab 480mg administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML Anti-PDL1
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML Anti-PDL1+CTLA4
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp NSCLC I-O Naive
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp NSCLC Anti-PDL1
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ASST
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp Renal
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 3: Melanoma and NSCLC
Reporting group description	BMS-986205 + nivolumab + ipilimumab triple therapy. BMS-986205 administered orally in tablet or capsule formulation. Nivolumab and ipilimumab administered as IV infusion.
Reporting group title	Unplanned - BMS50
Reporting group description	BMS-986205 50mg administered orally in tablet or capsule formulation.
Reporting group title	QTc Substudy
Reporting group description	BMS-986205 + nivolumab combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion.
Reporting group title	Food Effect/ Relative BA (FE BA) Substudy
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion.
Reporting group title	Unplanned
Reporting group description	Nivolumab 480mg administered as IV infusion.
Reporting group values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 2: Exp Pancreatic Part 2: Exp DLBCL Part 2: Exp SCCHN + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp Bladder + (IDO 200) Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp NSCLC I-O Naive Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp ASST Part 2: Exp Renal Part 3: Melanoma and NSCLC Unplanned - BMS50 QTc Substudy Food Effect/ Relative BA (FE BA) Substudy Unplanned Total Number of subjects 7 11 12 18 7 18 17 22 36 15 14 14 16 79 9 6 37 17 80 41 32 42 41 1 20 14 1 627 Age Categorical Units: Participants     >= 18 to < 65 years 5 8 9 13 5 16 15 13 15 9 7 6 7 41 6 4 20 10 52 20 19 23 26 1 11 10 0 371     >= 65 to < 85 years 2 3 3 5 2 2 2 9 21 6 7 8 9 37 3 2 16 7 28 21 13 18 15 0 9 4 1 253     >= 85 years 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 0 0 0 1 0 0 0 0 0 3 Sex: Female, Male Units: Participants     Female 6 6 9 10 4 18 17 7 12 3 2 2 3 26 3 2 14 6 27 17 27 8 12 0 16 9 1 267     Male 1 5 3 8 3 0 0 15 24 12 12 12 13 53 6 4 23 11 53 24 5 34 29 1 4 5 0 360 Race (NIH/OMB) Units: Subjects     American Indian or Alaska Native 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0     Asian 1 0 0 5 0 2 0 0 1 0 0 0 0 2 0 0 1 1 1 1 0 3 0 0 3 0 0 21     Native Hawaiian or Other Pacific Islander 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 0 0 0 0 3     Black or African American 1 1 1 1 0 0 0 0 1 0 0 0 0 0 0 0 1 0 4 2 3 0 1 0 2 1 0 19     White 5 10 10 11 6 15 16 21 32 15 14 14 16 70 7 6 28 16 64 33 29 39 36 1 15 13 1 543     More than one race 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0     Unknown or Not Reported 0 0 1 1 1 1 1 1 2 0 0 0 0 7 2 0 7 0 11 5 0 0 1 0 0 0 0 41 Ethnicity (NIH/OMB) Units: Subjects     Hispanic or Latino 0 1 0 0 0 1 0 3 1 0 1 2 2 2 0 0 0 0 0 1 0 3 1 0 0 0 0 18     Not Hispanic or Latino 4 7 7 10 4 8 8 7 4 2 8 3 6 43 3 5 16 5 38 15 17 21 32 0 15 14 0 302     Unknown or Not Reported 3 3 5 8 3 9 9 12 31 13 5 9 8 34 6 1 21 12 42 25 15 18 8 1 5 0 1 307
Subject analysis sets
Subject analysis set title	Part 1: BMS50 (ESC)
Subject analysis set type	Full analysis
Subject analysis set description	BMS-986205 50mg monotherapy. BMS-986205 administered orally in tablet or capsule formulation daily
Subject analysis set title	Part 1: BMS400 (ESC)
Subject analysis set type	Full analysis
Subject analysis set description	BMS-986205 400mg monotherapy. BMS-986205 administered orally in tablet or capsule formulation daily
Subject analysis sets values Part 1: BMS50 (ESC) Part 1: BMS400 (ESC) Number of subjects 1 1 Age Categorical Units: Participants     >= 18 to < 65 years 0 0     >= 65 to < 85 years 1 1     >= 85 years 0 0 Age continuous Units:      ( ) ( ) Sex: Female, Male Units: Participants     Female 1 1     Male 0 0 Race (NIH/OMB) Units: Subjects     American Indian or Alaska Native 0 0     Asian 0 0     Native Hawaiian or Other Pacific Islander 0 0     Black or African American 0 0     White 1 0     More than one race 0 0     Unknown or Not Reported 0 1 Ethnicity (NIH/OMB) Units: Subjects     Hispanic or Latino 0 0     Not Hispanic or Latino 1 0     Unknown or Not Reported 0 1

Baseline characteristics Top of page

End points Top of page
End points reporting groups
Reporting group title	Part 1: BMS25+NIV240(ESC)
Reporting group description	BMS-986205 25mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS50+NIV240(ESC)
Reporting group description	BMS-986205 50mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS100+NIV240(ESC)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS200+NIV240(ESC)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS400+NIV240(ESC)
Reporting group description	BMS-986205 400mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Cervical + (IDO 100)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Cervical + (IDO 200)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Pancreatic
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp DLBCL
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp SCCHN + (IDO 100)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp SCCHN + (IDO 200)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Bladder + (IDO 100)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Bladder + (IDO 200)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp ML I-O Naive
Reporting group description	BMS-986205 100mg+ nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML BRAF-MT
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML BRAF-MT- NIVO
Reporting group description	Nivolumab 480mg administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML Anti-PDL1
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML Anti-PDL1+CTLA4
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp NSCLC I-O Naive
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp NSCLC Anti-PDL1
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ASST
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp Renal
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 3: Melanoma and NSCLC
Reporting group description	BMS-986205 + nivolumab + ipilimumab triple therapy. BMS-986205 administered orally in tablet or capsule formulation. Nivolumab and ipilimumab administered as IV infusion.
Reporting group title	Unplanned - BMS50
Reporting group description	BMS-986205 50mg administered orally in tablet or capsule formulation.
Reporting group title	QTc Substudy
Reporting group description	BMS-986205 + nivolumab combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion.
Reporting group title	Food Effect/ Relative BA (FE BA) Substudy
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion.
Reporting group title	Unplanned
Reporting group description	Nivolumab 480mg administered as IV infusion.
Reporting group title	Part 1: BMS25+NIV240(ESC)
Reporting group description	BMS-986205 25mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS50+NIV240(ESC)
Reporting group description	BMS-986205 50mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS100+NIV240(ESC)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS200+NIV240(ESC)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS400+NIV240(ESC)
Reporting group description	BMS-986205 400mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Cervical + (IDO 100)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Cervical + (IDO 200)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Pancreatic
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp DLBCL
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp SCCHN + (IDO 100)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp SCCHN + (IDO 200)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Bladder + (IDO 100)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Bladder + (IDO 200)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp ML I-O Naive
Reporting group description	BMS-986205 100mg+ nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML BRAF-MT
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML BRAF-MT- NIVO
Reporting group description	Nivolumab 480mg administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML Anti-PDL1
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML Anti-PDL1+CTLA4
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp NSCLC I-O Naive
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp NSCLC Anti-PDL1
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ASST
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp Renal
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 3: Melanoma and NSCLC
Reporting group description	BMS-986205 + nivolumab + ipilimumab triple therapy. BMS-986205 administered orally in tablet or capsule formulation. Nivolumab and ipilimumab administered as IV infusion.
Reporting group title	Unplanned - BMS50
Reporting group description	BMS-986205 50mg administered orally in tablet or capsule formulation.
Reporting group title	QTc Substudy
Reporting group description	BMS-986205 + nivolumab combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion.
Reporting group title	Food Effect/ Relative BA (FE BA) Substudy
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion.
Reporting group title	Unplanned
Reporting group description	Nivolumab 480mg administered as IV infusion.
Subject analysis set title	Part 1: BMS50 (ESC)
Subject analysis set type	Full analysis
Subject analysis set description	BMS-986205 50mg monotherapy. BMS-986205 administered orally in tablet or capsule formulation daily
Subject analysis set title	Part 1: BMS400 (ESC)
Subject analysis set type	Full analysis
Subject analysis set description	BMS-986205 400mg monotherapy. BMS-986205 administered orally in tablet or capsule formulation daily

End points Top of page

Primary: Number of Participants with AEs, SAEs, AEs Leading to Discontinuation and Deaths Top of page
End point title	Number of Participants with AEs, SAEs, AEs Leading to Discontinuation and Deaths [1] [2]
End point description	Number of participants with adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuation and deaths.
End point type	Primary
End point timeframe	From first dose to 100 days after last dose (up to 15 months)
Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only summary statistics planned for this endpoint. [2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 2: Exp Pancreatic Part 2: Exp DLBCL Part 2: Exp SCCHN + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp Bladder + (IDO 200) Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp NSCLC I-O Naive Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp ASST Part 2: Exp Renal Part 3: Melanoma and NSCLC Unplanned - BMS50 Unplanned Part 1: BMS50 (ESC) Part 1: BMS400 (ESC) Number of subjects analysed 7 10 12 18 6 18 17 22 35 15 14 14 16 79 9 6 37 17 80 41 32 42 41 1 1 1 1 Units: Participants     Adverse Events 7 10 11 18 6 18 17 21 34 15 14 14 16 79 8 6 35 17 80 39 31 41 41 0 1 1 1     Serious Adverse Events 5 6 8 12 5 15 14 18 27 12 9 12 11 42 8 1 18 10 50 32 22 22 22 0 1 1 1     AEs Leading to Discontinuation 1 1 4 4 0 2 0 7 6 3 4 2 6 16 1 1 3 4 15 6 7 3 1 0 0 1 1     Deaths 6 8 9 15 4 16 12 21 21 11 12 9 12 34 6 2 26 12 59 34 22 19 16 0 0 1 1
No statistical analyses for this end point

Primary: Number of Participants with AEs, SAEs, AEs Leading to Discontinuation and Deaths Top of page

Primary: Number of Treated Participant with Laboratory Abnormalities - Thyroid Top of page
End point title	Number of Treated Participant with Laboratory Abnormalities - Thyroid [3] [4]
End point description	The number of treated participants who experienced a laboratory abnormality of the thyroid during the course of the study. Free T3 (FT3) Free T4 (FT4) Thyroid stimulating hormone (TSH) Lower Limit of Normal (LLN) Upper limit of normal (ULN) Results reported in International System of Units (SI)
End point type	Primary
End point timeframe	From first dose to 100 days after last dose (up to 15 months)
Notes [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only summary statistics planned for this endpoint. [4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 2: Exp Pancreatic Part 2: Exp DLBCL Part 2: Exp SCCHN + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp Bladder + (IDO 200) Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp NSCLC I-O Naive Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp ASST Part 2: Exp Renal Part 3: Melanoma and NSCLC Unplanned - BMS50 Unplanned Part 1: BMS50 (ESC) Part 1: BMS400 (ESC) Number of subjects analysed 6 8 9 12 4 13 14 13 23 11 10 14 14 77 8 6 32 14 67 34 27 38 38 0 [5] 1 0 [6] 0 [7] Units: Participants     TSH > ULN 1 1 2 2 3 4 7 1 2 6 6 3 4 19 1 1 5 4 16 4 9 17 15 0     TSH > ULN with TSH ≤ ULN at baseline 1 1 1 2 2 1 7 1 2 4 4 3 3 17 1 1 1 1 13 1 8 10 12 0     TSH>ULN with at least one FT3/FT4 test value<LLN 0 0 1 2 1 2 5 1 1 4 2 2 3 15 0 0 3 1 5 1 7 9 4 0     TSH < LLN 0 0 3 1 1 1 2 2 2 2 3 3 2 17 2 1 3 5 25 4 8 9 10 1     TSH < LLN with TSH ≥ LLN at baseline 0 0 2 1 1 1 2 2 2 1 0 3 2 15 2 1 3 4 19 3 7 7 8 1     TSH<LLN with at least one FT3/FT4 test value>ULN 0 0 1 0 0 1 1 1 0 1 1 0 0 5 1 0 1 1 7 0 3 4 4 1
Notes [5] - Insufficient number of participants with an event [6] - Insufficient number of participants with an event [7] - Insufficient number of participants with an event
No statistical analyses for this end point

Primary: Number of Treated Participant with Laboratory Abnormalities - Thyroid Top of page

Primary: Number of Treated Participant with Laboratory Abnormalities - Liver Top of page
End point title	Number of Treated Participant with Laboratory Abnormalities - Liver [8] [9]
End point description	The number of treated participants who experienced a laboratory abnormality of the liver during the course of the study. Aspartate aminotransferase (AST) Alanine aminotransferase (ALT) Upper Limit of Normal (ULN) Results reported in International System of Units (SI)
End point type	Primary
End point timeframe	From first dose to 100 days after last dose (up to 15 months)
Notes [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only summary statistics planned for this endpoint. [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 2: Exp Pancreatic Part 2: Exp DLBCL Part 2: Exp SCCHN + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp Bladder + (IDO 200) Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp NSCLC I-O Naive Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp ASST Part 2: Exp Renal Part 3: Melanoma and NSCLC Unplanned - BMS50 Unplanned Part 1: BMS50 (ESC) Part 1: BMS400 (ESC) Number of subjects analysed 7 10 12 18 6 18 17 22 34 14 14 14 16 79 9 6 37 17 80 40 32 41 41 0 [10] 1 1 1 Units: Participants     ALT OR AST > 3XULN 2 1 1 7 3 1 6 6 5 1 2 3 5 21 2 0 4 2 15 4 7 4 15 1 0 1     ALT OR AST> 5XULN 0 0 1 5 2 1 1 4 4 0 2 2 4 16 2 0 4 1 10 4 5 2 12 0 0 0     ALT OR AST> 10XULN 0 0 1 1 0 1 0 0 1 0 0 1 3 7 0 0 3 0 8 2 1 1 4 0 0 0     ALT OR AST > 20XULN 0 0 0 0 0 0 0 0 0 0 0 1 1 5 0 0 1 0 3 1 0 1 2 0 0 0     TOTAL BILIRUBIN > 2XULN 0 0 0 0 0 0 0 6 2 0 1 1 3 4 1 0 1 2 2 2 1 1 0 0 0 0     ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN - 1 DAY 0 0 0 0 0 0 0 3 0 0 1 0 3 3 1 0 1 2 2 1 1 0 0 0 0 0     ALT/AST ELEV>3XULN;TOTAL BILIRUBIN>2XULN - 30 DAYS 0 0 0 0 0 0 0 3 0 0 1 0 3 3 1 0 1 2 2 2 1 0 0 0 0 0
Notes [10] - Insufficient number of participants with an event
No statistical analyses for this end point

Primary: Number of Treated Participant with Laboratory Abnormalities - Liver Top of page

Primary: Number of Participants with a Best Overall Response (BOR) - Parts 2 and 3 Top of page
End point title	Number of Participants with a Best Overall Response (BOR) - Parts 2 and 3 [11] [12]
End point description	Best overall response (BOR) is defined as the best response designation over the study as a whole. Complete response (CR) or partial response (PR) determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met. For those participants who have surgical resection, only pre-surgical tumor assessments will be considered in the determination of BOR. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease. (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Appearance of 1 or more new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
End point type	Primary
End point timeframe	From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Notes [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only summary statistics planned for this endpoint. [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 2: Exp Pancreatic Part 2: Exp DLBCL Part 2: Exp SCCHN + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp Bladder + (IDO 200) Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp NSCLC I-O Naive Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp ASST Part 2: Exp Renal Part 3: Melanoma and NSCLC Number of subjects analysed 18 17 22 35 15 14 14 16 79 9 6 37 17 80 41 32 42 41 Units: Participants     Complete response (CR) 0 0 0 0 0 1 1 2 15 3 2 0 0 2 0 0 0 5     Partial response (PR) 0 4 1 5 2 3 5 3 17 1 1 1 2 12 4 3 8 12     Stable disease (SD) 6 8 1 5 6 4 0 4 14 2 1 11 3 28 14 10 13 11     Progressive disease (PD) 10 3 17 20 3 2 8 6 29 3 2 23 9 28 21 15 17 9     Unable to determine (UTD) 2 2 3 5 4 4 0 1 4 0 0 2 3 10 2 4 4 4
No statistical analyses for this end point

Primary: Number of Participants with a Best Overall Response (BOR) - Parts 2 and 3 Top of page

Primary: Percentage of Participants with an Objective Response Rate (ORR)- Parts 2 and 3 Top of page
End point title	Percentage of Participants with an Objective Response Rate (ORR)- Parts 2 and 3 [13] [14]
End point description	Objective response rate (ORR) is defined as the percentage of all treated participants whose BOR is either a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.
End point type	Primary
End point timeframe	From first dose to the last tumor assessment prior to subsequent therapy (up to a maximum of 185 weeks)
Notes [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only summary statistics planned for this endpoint. [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 2: Exp Pancreatic Part 2: Exp DLBCL Part 2: Exp SCCHN + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp Bladder + (IDO 200) Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp NSCLC I-O Naive Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp ASST Part 2: Exp Renal Part 3: Melanoma and NSCLC Number of subjects analysed 18 17 22 35 15 14 14 16 79 9 6 37 17 80 41 32 42 41 Units: Percentage of participants     number (confidence interval 95%) 0 (0 to 18.5) 23.5 (6.8 to 49.9) 4.5 (0.1 to 22.8) 14.3 (4.8 to 30.3) 13.3 (1.7 to 40.5) 28.6 (8.4 to 58.1) 42.9 (17.7 to 71.1) 31.3 (11.0 to 58.7) 40.5 (29.6 to 52.1) 44.4 (13.7 to 78.8) 50.0 (11.8 to 88.2) 2.7 (0.1 to 14.2) 11.8 (1.5 to 36.4) 17.5 (9.9 to 27.6) 9.8 (2.7 to 23.1) 9.4 (2.0 to 25.0) 19 (8.6 to 34.1) 41.5 (26.3 to 57.9)
No statistical analyses for this end point

Primary: Percentage of Participants with an Objective Response Rate (ORR)- Parts 2 and 3 Top of page

Primary: Median Duration of Response (DoR) - Parts 2 and 3 Top of page
End point title	Median Duration of Response (DoR) - Parts 2 and 3 [15] [16]
End point description	Duration of response (DoR) was computed for all treated subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Please note: 99999=Not Available.
End point type	Primary
End point timeframe	From first dose to the date of disease progression, death, or until participants withdraw from the study, whichever occurs first (up to a maximum of 185 weeks)
Notes [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only summary statistics planned for this endpoint. [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 2: Exp Pancreatic Part 2: Exp DLBCL Part 2: Exp SCCHN + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp Bladder + (IDO 200) Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp NSCLC I-O Naive Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp ASST Part 2: Exp Renal Part 3: Melanoma and NSCLC Number of subjects analysed 0 [17] 4 1 5 2 4 6 5 32 4 3 1 2 14 4 3 8 17 Units: Weeks     median (confidence interval 95%) ( to ) 134.14 (12.71 to 99999) 99999 (99999 to 99999) 42.57 (13.29 to 99999) 99999 (40.14 to 99999) 76.14 (16 to 99999) 99999 (16.14 to 99999) 99999 (35.86 to 99999) 144.14 (84.57 to 99999) 99999 (24 to 99999) 99999 (99999 to 99999) 99999 (99999 to 99999) 55.14 (39.14 to 99999) 51.79 (26.43 to 99999) 32.14 (17.29 to 99999) 99999 (64.43 to 99999) 32.07 (16 to 98.14) 99999 (67.14 to 99999)
Notes [17] - Only analyzed for participants who achieved a response (CR or PR)
No statistical analyses for this end point

Primary: Median Duration of Response (DoR) - Parts 2 and 3 Top of page

Primary: Progression Free Survival Rate (PFSR) - Parts 2 and 3 Top of page
End point title	Progression Free Survival Rate (PFSR) - Parts 2 and 3 [18] [19]
End point description	Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at the specified timepoints (24 weeks, 1 year, and 2 years). Reported values are estimates derived from Kaplan-Meier analyses. Please note: 99999=Not Available.
End point type	Primary
End point timeframe	From first dose to 24 weeks, to 1 year, and to 2 years after first dose
Notes [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: Only summary statistics planned for this endpoint. [19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 2: Exp Pancreatic Part 2: Exp DLBCL Part 2: Exp SCCHN + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp Bladder + (IDO 200) Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp NSCLC I-O Naive Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp ASST Part 2: Exp Renal Part 3: Melanoma and NSCLC Number of subjects analysed 18 17 22 35 15 14 14 16 79 9 6 37 17 80 41 32 42 41 Units: Percentage of participants number (confidence interval 95%)     24 weeks 6.6 (0.4 to 25.8) 38.0 (15.7 to 60.3) 4.5 (0.3 to 18.9) 24.2 (11.4 to 39.6) 20.0 (4.9 to 42.4) 42.9 (17.7 to 66.0) 42.9 (17.7 to 66.0) 37.5 (15.4 to 59.8) 48.2 (36.5 to 58.9) 53.3 (17.7 to 79.6) 50 (11.1 to 80.4) 15.1 (5.6 to 29) 17.6 (4.3 to 38.3) 37.3 (26.6 to 48) 23.7 (11.8 to 37.9) 36.4 (19.8 to 53.2) 34.8 (20.5 to 49.5) 56 (39 to 69.9)     1- year 99999 (99999 to 99999) 19.0 (4.7 to 40.6) 4.5 (0.3 to 18.9) 8.1 (1.7 to 21.2) 13.3 (2.2 to 34.6) 34.3 (11.6 to 58.7) 28.6 (8.8 to 52.4) 31.3 (11.4 to 53.6) 39.8 (28.7 to 50.7) 26.7 (4.1 to 57.9) 50 (11.1 to 80.4) 6 (1.1 to 17.5) 11.8 (2 to 31.2) 20.9 (12.5 to 30.7) 5.3 (1 to 15.5) 20.2 (7.7 to 36.9) 10.7 (3.4 to 22.8) 47.3 (30.7 to 62.1)     2-years 99999 (99999 to 99999) 12.7 (2.1 to 33.1) 4.5 (0.3 to 18.9) 4.0 (0.3 to 16.4) 6.7 (0.4 to 26.0) 8.6 (0.5 to 31.5) 21.4 (5.2 to 44.8) 25.0 (7.8 to 47.2) 34.0 (23.4 to 44.9) 26.7 (4.1 to 57.9) 50 (11.1 to 80.4) 6 (1.1 to 17.5) 11.8 (2 to 31.2) 8.3 (3.4 to 16.1) 2.6 (0.2 to 11.8) 12.1 (3.2 to 27.5) 5.4 (1 to 15.7) 31.8 (16.2 to 48.7)
No statistical analyses for this end point

Primary: Progression Free Survival Rate (PFSR) - Parts 2 and 3 Top of page

Secondary: Cmax Top of page
End point title	Cmax [20]
End point description	Cmax is defined as the maximum observed plasma concentration. Pharmacokinetic parameters measured here are for BMS-986205.
End point type	Secondary
End point timeframe	At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks]
Notes [20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Number of subjects analysed 7 11 12 18 7 Units: ng/mL geometric mean (geometric coefficient of variation)     Cycle 0, Day 1 94.884 ( 43 ) 148.975 ( 69 ) 349.767 ( 57 ) 613.202 ( 60 ) 1248.062 ( 107 )     Cycle 0, Day 14 152.082 ( 33 ) 220.196 ( 44 ) 475.745 ( 32 ) 1091.549 ( 50 ) 1912.682 ( 61 )
No statistical analyses for this end point

Secondary: Cmax Top of page

Secondary: AUC(TAU) Top of page
End point title	AUC(TAU) [21]
End point description	AUC(TAU) is defined as the area under the concentration-time curve in 1 dosing interval. Pharmacokinetic parameters measured here are for BMS-986205.
End point type	Secondary
End point timeframe	Cycle 0 Day 1 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 0 Day 14 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose)
Notes [21] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Number of subjects analysed 7 11 12 18 7 Units: h*ng/mL geometric mean (geometric coefficient of variation)     Cycle 0, Day 1 700.886 ( 30 ) 1125.546 ( 54 ) 2271.901 ( 53 ) 5091.460 ( 53 ) 10479.864 ( 73 )     Cycle 0, Day 14 2079.137 ( 23 ) 2531.139 ( 65 ) 4949.909 ( 54 ) 13073.275 ( 41 ) 19473.051 ( 46 )
No statistical analyses for this end point

Secondary: AUC(TAU) Top of page

Secondary: Tmax Top of page
End point title	Tmax [22]
End point description	Tmax is defined as the time of maximum observed plasma concentration. Pharmacokinetic parameters measured here are for BMS-986205.
End point type	Secondary
End point timeframe	At cycle 0 day 1 and day 14 [cycle 0= up to 2 weeks]
Notes [22] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Number of subjects analysed 7 11 12 18 7 Units: hours median (full range (min-max))     Cycle 0, Day 1 3.050 (2.95 to 6) 3 (2.07 to 8.15) 4.025 (1.08 to 8.08) 4.009 (2 to 7.92) 4.300 (2.08 to 24.58)     Cycle 0, Day 14 3 (1.95 to 3.12) 4 (2 to 6.12) 3.025 (2 to 8.13) 3.017 (1 to 8) 3 (2.05 to 28.45)
No statistical analyses for this end point

Secondary: Tmax Top of page

Secondary: Ctrough Top of page
End point title	Ctrough
End point description	Ctrough is defined as the trough observed plasma concentration at the end of the dosing interval. Please note: 99999=Not Available.
End point type	Secondary
End point timeframe	At cycles 0 [up to 2 weeks] and at cycles 3, 5, 7, 10, 11, 13, 15 [each cycle is up to 4 weeks]
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 2: Exp Pancreatic Part 2: Exp DLBCL Part 2: Exp SCCHN + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp Bladder + (IDO 200) Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp NSCLC I-O Naive Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp ASST Part 2: Exp Renal Part 3: Melanoma and NSCLC Unplanned - BMS50 QTc Substudy Food Effect/ Relative BA (FE BA) Substudy Unplanned Part 1: BMS50 (ESC) Part 1: BMS400 (ESC) Number of subjects analysed 6 11 12 18 7 3 7 2 14 4 5 4 3 51 5 0 [23] 15 8 28 10 11 22 0 [24] 0 [25] 0 [26] 14 0 [27] 0 [28] 0 [29] Units: ng/mL geometric mean (geometric coefficient of variation)     Cycle 0, Day 2 12.020 ( 37 ) 22.216 ( 64 ) 33.918 ( 82 ) 90.605 ( 61 ) 225.065 ( 60 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) ( ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) ( ) ( ) ( ) 99999 ( 99999 ) ( ) ( ) ( )     Cycle 0, Day 8 53.307 ( 110 ) 100.238 ( 76 ) 86.651 ( 155 ) 322.492 ( 38 ) 582.580 ( 83 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) ( ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) ( ) ( ) ( ) 10.021 ( 106 ) ( ) ( ) ( )     Cycle 0, Day 14 53.522 ( 50 ) 65.590 ( 100 ) 112.154 ( 84 ) 332.165 ( 66 ) 373.479 ( 213 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) ( ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) ( ) ( ) ( ) 99999 ( 99999 ) ( ) ( ) ( )     Cycle 3, Day 1 38.862 ( 91 ) 76.193 ( 1 ) 190.984 ( 79 ) 374.882 ( 86 ) 255.592 ( 99999 ) 281.639 ( 83 ) 394.303 ( 42 ) 99999 ( 99999 ) 140.834 ( 62 ) 139.560 ( 79 ) 240.978 ( 87 ) 121.641 ( 52 ) 252.083 ( 8 ) 121.650 ( 72 ) 200.303 ( 29 ) ( ) 127.464 ( 144 ) 82.588 ( 202 ) 126.298 ( 60 ) 86.613 ( 1021 ) 145.265 ( 46 ) 114.018 ( 72 ) ( ) ( ) ( ) 137.123 ( 71 ) ( ) ( ) ( )     Cycle 5, Day 1 52.371 ( 19 ) 23.974 ( 305 ) 412.812 ( 99999 ) 251.690 ( 79 ) 99999 ( 99999 ) 147 ( 99999 ) 375.415 ( 47 ) 39.556 ( 37 ) 183.272 ( 69 ) 133.796 ( 99 ) 201.574 ( 63 ) 169.231 ( 114 ) 251.110 ( 23 ) 110.097 ( 63 ) 263.717 ( 91 ) ( ) 96.255 ( 162 ) 106.315 ( 57 ) 149.506 ( 55 ) 167.949 ( 21 ) 188.233 ( 50 ) 105.164 ( 107 ) ( ) ( ) ( ) 78.595 ( 101 ) ( ) ( ) ( )     Cycle 7, Day 1 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 573.328 ( 59 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 41.3 ( 99999 ) 144.312 ( 30 ) 246.552 ( 45 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 120.596 ( 79 ) 99999 ( 99999 ) ( ) 35.608 ( 443 ) 99999 ( 99999 ) 103.057 ( 64 ) 149 ( 99999 ) 84.598 ( 168 ) 117.556 ( 43 ) ( ) ( ) ( ) 161.750 ( 95 ) ( ) ( ) ( )     Cycle 10, Day 1 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 390 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 397.233 ( 15 ) 55.7 ( 99999 ) 99999 ( 99999 ) 65.1 ( 99999 ) 99999 ( 99999 ) 305.405 ( 22 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) ( ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) ( ) ( ) ( ) 99999 ( 99999 ) ( ) ( ) ( )     Cycle 11, Day 1 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 427 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 350 ( 99999 ) 99999 ( 99999 ) 95.121 ( 65 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 150.150 ( 80 ) 237.382 ( 45 ) ( ) 160.792 ( 21 ) 99999 ( 99999 ) 137.222 ( 76 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) ( ) ( ) ( ) 99999 ( 99999 ) ( ) ( ) ( )     Cycle 13, Day 1 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 55 ( 99999 ) 99999 ( 99999 ) 53.072 ( 29 ) 99999 ( 99999 ) 372 ( 99999 ) 336 ( 99999 ) ( ) 99999 ( 99999 ) 99999 ( 99999 ) 129 ( 99999 ) 99999 ( 99999 ) 411 ( 99999 ) 99999 ( 99999 ) ( ) ( ) ( ) 99999 ( 99999 ) ( ) ( ) ( )     Cycle 15, Day 1 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 1650 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) 84.014 ( 77 ) 99999 ( 99999 ) 287 ( 99999 ) 104.517 ( 318 ) 171 ( 99999 ) 109.168 ( 63 ) 99999 ( 99999 ) ( ) 11.2 ( 99999 ) 99999 ( 99999 ) 104.957 ( 38 ) 99999 ( 99999 ) 99999 ( 99999 ) 99999 ( 99999 ) ( ) ( ) ( ) 99999 ( 99999 ) ( ) ( ) ( )
Notes [23] - Analyzed in participants only with evaluable pharmacokinetic measurements [24] - Analyzed in participants only with evaluable pharmacokinetic measurements [25] - Analyzed in participants only with evaluable pharmacokinetic measurements [26] - Analyzed in participants only with evaluable pharmacokinetic measurements [27] - Analyzed in participants only with evaluable pharmacokinetic measurements [28] - Analyzed in participants only with evaluable pharmacokinetic measurements [29] - Analyzed in participants only with evaluable pharmacokinetic measurements
No statistical analyses for this end point

Secondary: Ctrough Top of page

Secondary: Accumulation Index (AI) - AUC(TAU) Top of page
End point title	Accumulation Index (AI) - AUC(TAU) [30]
End point description	Accumulation index (AI) of AUC(TAU) is calculated based on the ratio of AUC(TAU) and Cmax at steady state to after the first dose. Pharmacokinetic parameters measured here are for BMS-986205.
End point type	Secondary
End point timeframe	Cycle 0 Day 1 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose), Cycle 0 Day 14 (0, 1, 2, 3, 4, 6, 8, 24 hours post-dose)
Notes [30] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Number of subjects analysed 7 11 12 18 7 Units: Ratio geometric mean (geometric coefficient of variation)     AI_AUC(TAU) at Cycle 0 Day 14 2.966 ( 20 ) 2.380 ( 67 ) 2.290 ( 63 ) 2.360 ( 43 ) 1.9 ( 49 )
No statistical analyses for this end point

Secondary: Accumulation Index (AI) - AUC(TAU) Top of page

Secondary: CLT/F Top of page
End point title	CLT/F [31]
End point description	CLT/F is defined as the apparent total body clearance. Pharmacokinetic parameters measured here are for BMS-986205.
End point type	Secondary
End point timeframe	At Cycle 0 Day 14 [cycle 0 = up to 2 weeks]
Notes [31] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Number of subjects analysed 7 10 11 14 6 Units: L/h     geometric mean (geometric coefficient of variation) 12.024 ( 23 ) 19.754 ( 65 ) 20.202 ( 54 ) 15.298 ( 41 ) 20.541 ( 46 )
No statistical analyses for this end point

Secondary: CLT/F Top of page

Secondary: Accumulation Index (AI) - Cmax Top of page
End point title	Accumulation Index (AI) - Cmax [32]
End point description	Accumulation index (AI) of Cmax is calculated based on the ratio of Cmax at steady state to after the first dose. Pharmacokinetic parameters measured here are for BMS-986205.
End point type	Secondary
End point timeframe	At Cycle 0 Day 14 [cycle 0 = up to 2 weeks]
Notes [32] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Number of subjects analysed 7 11 12 18 7 Units: Ratio     geometric mean (geometric coefficient of variation) 1.603 ( 45 ) 1.523 ( 55 ) 1.360 ( 66 ) 1.646 ( 59 ) 1.505 ( 52 )
No statistical analyses for this end point

Secondary: Accumulation Index (AI) - Cmax Top of page

Secondary: Change from Baseline in Serum Kynurenine Top of page
End point title	Change from Baseline in Serum Kynurenine [33]
End point description	Pharmacodynamics assessed by change from baseline in serum kynurenine. Changes in kynurenine expression were evaluated in serum samples from participants treated using liquid chromatography with tandem mass spectrometry (LC-MS/MS). Kynurenine is an important metabolite of the IDO-1 Enzyme. Change in Kynurenine levels from baseline is an important indicator of BMS-986205 (IDO1 inhibitor) pharmacodynamic activity. Please note: 99999=Not Available.
End point type	Secondary
End point timeframe	At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks]
Notes [33] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 2: Exp Pancreatic Part 2: Exp DLBCL Part 2: Exp SCCHN + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp Bladder + (IDO 200) Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp NSCLC I-O Naive Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp ASST Part 2: Exp Renal Part 3: Melanoma and NSCLC Unplanned - BMS50 Unplanned Part 1: BMS50 (ESC) Part 1: BMS400 (ESC) Number of subjects analysed 7 10 12 18 6 18 17 22 35 15 14 14 16 79 9 6 37 17 80 41 32 42 0 [34] 0 [35] 0 [36] 1 1 Units: microMolars arithmetic mean (standard deviation)     Change from baseline (Cycle 1, day 15) -208.7 ( 112 ) -262 ( 111.2 ) -369.7 ( 200.8 ) -314 ( 243.3 ) -326.4 ( 193.8 ) -378.1 ( 241.1 ) -361.9 ( 153.3 ) -278.6 ( 214.4 ) -391 ( 230.1 ) -281.9 ( 144.1 ) -495.1 ( 281.6 ) -331.5 ( 199.1 ) -398.9 ( 155.5 ) -371.8 ( 171.5 ) -386.4 ( 109 ) 124.4 ( 141.3 ) -399 ( 161 ) -325.4 ( 117.6 ) -360.7 ( 162.3 ) -487.2 ( 193 ) -317.8 ( 134.7 ) -427.4 ( 156.4 ) ( ) ( ) ( ) 99999 ( 99999 ) 99999 ( 99999 )
Notes [34] - Only analyzed in participants with evaluable serum kynurenine measurements [35] - Only analyzed in participants with evaluable serum kynurenine measurements [36] - Only analyzed in participants with evaluable serum kynurenine measurements
No statistical analyses for this end point

Secondary: Change from Baseline in Serum Kynurenine Top of page

Secondary: Percent Change from Baseline in Serum Kynurenine Top of page
End point title	Percent Change from Baseline in Serum Kynurenine [37]
End point description	Pharmacodynamics assessed by change from baseline in serum kynurenine. Changes in kynurenine expression were evaluated in serum samples from participants treated using liquid chromatography with tandem mass spectrometry (LC-MS/MS). Kynurenine is an important metabolite of the IDO-1 Enzyme. Change in Kynurenine levels from baseline is an important indicator of BMS-986205 (IDO1 inhibitor) pharmacodynamic activity. Please note: 99999=Not Available.
End point type	Secondary
End point timeframe	At baseline (cycle 1, day 1) and at cycle 1, day 15 [cycle 1 = up to 4 weeks]
Notes [37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 2: Exp Pancreatic Part 2: Exp DLBCL Part 2: Exp SCCHN + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp Bladder + (IDO 200) Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp NSCLC I-O Naive Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp ASST Part 2: Exp Renal Part 3: Melanoma and NSCLC Unplanned - BMS50 Unplanned Part 1: BMS50 (ESC) Part 1: BMS400 (ESC) Number of subjects analysed 7 10 12 18 6 18 17 22 35 15 14 14 16 79 9 6 37 17 80 41 32 42 0 [38] 0 [39] 0 [40] 1 1 Units: Percent change arithmetic mean (standard deviation)     Percent change (Cycle 1, day 15) -37.7 ( 14.1 ) -46.6 ( 16.1 ) -56.4 ( 14.9 ) -44.7 ( 31.1 ) -44.1 ( 23.6 ) -54 ( 22.1 ) -61 ( 9.6 ) -46.9 ( 15.8 ) -53.2 ( 20.4 ) -49.4 ( 24.8 ) -57 ( 22.3 ) -49.3 ( 20.3 ) -56.5 ( 15.2 ) -57.8 ( 13.2 ) -57.9 ( 15.6 ) 24.7 ( 23.8 ) -61.3 ( 12.8 ) -56.5 ( 11.9 ) -55.2 ( 14.2 ) -61.5 ( 11.8 ) -50.8 ( 17.6 ) -55.3 ( 11.2 ) ( ) ( ) ( ) 99999 ( 99999 ) 99999 ( 99999 )
Notes [38] - Only analyzed in participants with evaluable serum kynurenine measurements [39] - Only analyzed in participants with evaluable serum kynurenine measurements [40] - Only analyzed in participants with evaluable serum kynurenine measurements
No statistical analyses for this end point

Secondary: Percent Change from Baseline in Serum Kynurenine Top of page

Secondary: Number of Participants with a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies Top of page
End point title	Number of Participants with a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies [41]
End point description	Best overall response (BOR) is defined as the best response designation over the study as a whole. Complete response (CR) or partial response (PR) determinations included in the BOR assessment must be confirmed by a second scan performed no less than 4 weeks after the criteria for response are first met. For those participants who have surgical resection, only pre-surgical tumor assessments will be considered in the determination of BOR. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Progressive Disease. (PD): At least a 20% increase in the sum of diameters of target lesions and an absolute increase of at least 5 mm. Appearance of 1 or more new lesions is also considered progression. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD.
End point type	Secondary
End point timeframe	From first dose to the last tumor assessment prior to subsequent therapy (up to approximately 48 weeks)
Notes [41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) QTc Substudy Food Effect/ Relative BA (FE BA) Substudy Part 1: BMS50 (ESC) Part 1: BMS400 (ESC) Number of subjects analysed 7 10 12 18 6 20 14 1 1 Units: Participants     Complete response (CR) 0 0 0 0 0 0 1 0 0     Partial response (PR) 0 1 0 1 0 1 1 0 0     Stable disease (SD) 2 3 4 4 2 2 3 0 0     Progressive disease (PD) 5 5 7 9 4 14 7 0 0     Unable to determine (UTD) 0 1 1 4 0 3 2 1 1
No statistical analyses for this end point

Secondary: Number of Participants with a Best Overall Response (BOR) - Part 1 and Clinical Pharmacology Substudies Top of page

Secondary: Percentage of Participants with an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies Top of page
End point title	Percentage of Participants with an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies [42]
End point description	Objective response rate (ORR) is defined as the percentage of all treated participants whose BOR is either a complete response (CR) or partial response (PR). Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. CR+PR confidence interval based on the Clopper and Pearson method.
End point type	Secondary
End point timeframe	From first dose to the last tumor assessment prior to subsequent therapy (up to approximately 48 weeks)
Notes [42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) QTc Substudy Food Effect/ Relative BA (FE BA) Substudy Part 1: BMS50 (ESC) Part 1: BMS400 (ESC) Number of subjects analysed 7 10 12 18 6 20 14 1 1 Units: Percentage of participants     number (confidence interval 95%) 0 (0 to 41.0) 10 (0.3 to 44.5) 0 (0 to 26.5) 5.6 (0.1 to 27.3) 0 (0 to 45.9) 5 (0.1 to 24.9) 14.3 (1.8 to 42.8) 0 (0 to 97.5) 0 (0 to 97.5)
No statistical analyses for this end point

Secondary: Percentage of Participants with an Objective Response Rate (ORR) - Part 1 and Clinical Pharmacology Substudies Top of page

Secondary: Median Duration of Response (DoR) - Part 1 and Clinical Pharmacology Substudies Top of page
End point title	Median Duration of Response (DoR) - Part 1 and Clinical Pharmacology Substudies [43]
End point description	Duration of response (DoR) was computed for all treated subjects with a best overall response (BOR) of complete response (CR) or partial response (PR) and is defined as the time between the date of first response and the date of disease progression or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions. Please note: 99999=Not Available.
End point type	Secondary
End point timeframe	From first dose to the last tumor assessment prior to subsequent therapy (up to approximately 48 weeks)
Notes [43] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) QTc Substudy Food Effect/ Relative BA (FE BA) Substudy Part 1: BMS50 (ESC) Part 1: BMS400 (ESC) Number of subjects analysed 0 [44] 1 0 [45] 1 0 [46] 1 2 0 [47] 0 [48] Units: Weeks     median (confidence interval 95%) ( to ) 52.14 (0.99999 to 99999) ( to ) 99999 (99999 to 99999) ( to ) 99999 (99999 to 99999) 99999 (24.29 to 99999) ( to ) ( to )
Notes [44] - Only analyzed for participants who achieved a response (CR or PR) [45] - Only analyzed for participants who achieved a response (CR or PR) [46] - Only analyzed for participants who achieved a response (CR or PR) [47] - Only analyzed for participants who achieved a response (CR or PR) [48] - Only analyzed for participants who achieved a response (CR or PR)
No statistical analyses for this end point

Secondary: Median Duration of Response (DoR) - Part 1 and Clinical Pharmacology Substudies Top of page

Secondary: Progression Free Survival Rate (PFSR) - Part 1 and Clinical Pharmacology Substudies Top of page
End point title	Progression Free Survival Rate (PFSR) - Part 1 and Clinical Pharmacology Substudies [49]
End point description	Progression free survival rate (PFSR) is defined as the percentage of participants who remain progression free and surviving at the specified timepoints (24 weeks, 1 year, and 2 years). Reported values are estimates derived from Kaplan-Meier analyses. Please note: 99999=Not Available.
End point type	Secondary
End point timeframe	From first dose to 24 weeks, to 1 year, and to 2 years after first dose
Notes [49] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) QTc Substudy Food Effect/ Relative BA (FE BA) Substudy Part 1: BMS50 (ESC) Part 1: BMS400 (ESC) Number of subjects analysed 7 10 12 18 6 20 14 1 1 Units: Percentage of participants number (confidence interval 95%)     24 weeks 14.3 (0.7 to 46.5) 30.0 (7.1 to 57.8) 30.7 (7.3 to 58.6) 28.2 (9.6 to 50.5) 99999 (99999 to 99999) 10.5 (1.8 to 28.4) 35.7 (13 to 59.4) 99999 (99999 to 99999) 99999 (99999 to 99999)     1-year 99999 (99999 to 99999) 15 (1 to 45.7) 99999 (99999 to 99999) 21.2 (5.6 to 43.4) 99999 (99999 to 99999) 10.5 (1.8 to 28.4) 14.3 (2.3 to 36.6) 99999 (99999 to 99999) 99999 (99999 to 99999)     2-years 99999 (99999 to 99999) 99999 (99999 to 99999) 99999 (99999 to 99999) 7.1 (0.5 to 27) 99999 (99999 to 99999) 5.3 (0.4 to 21.4) 7.1 (0.5 to 27.5) 99999 (99999 to 99999) 99999 (99999 to 99999)
No statistical analyses for this end point

Secondary: Progression Free Survival Rate (PFSR) - Part 1 and Clinical Pharmacology Substudies Top of page

Secondary: Number of Participants with a Positive Anti-Drug Antibody (ADA) Test Top of page
End point title	Number of Participants with a Positive Anti-Drug Antibody (ADA) Test [50]
End point description	A participant with at least one ADA-positive sample relative to baseline after initiation of treatment with nivolumab or ipilimumab. ADA-Positive after initiation of treatment was defined as (1) an ADA detected (positive seroconversion) sample in a subject for whom ADA is not detected at baseline, or (2) an ADA detected sample with ADA titer to be at least 4-fold or greater (≥) than baseline positive titer.
End point type	Secondary
End point timeframe	From first dose to last dose (up to approximately 48 weeks)
Notes [50] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Endpoints are cohort specific and do not report for all arms.
End point values Part 1: BMS25+NIV240(ESC) Part 1: BMS50+NIV240(ESC) Part 1: BMS100+NIV240(ESC) Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 2: Exp Pancreatic Part 2: Exp DLBCL Part 2: Exp SCCHN + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp Bladder + (IDO 200) Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp NSCLC I-O Naive Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp ASST Part 2: Exp Renal Part 3: Melanoma and NSCLC Unplanned - BMS50 Unplanned Part 1: BMS50 (ESC) Part 1: BMS400 (ESC) Number of subjects analysed 5 6 8 9 1 10 13 9 24 11 9 11 12 71 7 5 30 12 66 33 25 36 35 0 [51] 0 [52] 0 [53] 0 [54] Units: Participants     Nivolumab ADA+ 1 0 0 0 0 1 2 2 0 0 2 1 1 1 0 0 0 0 6 0 1 3 2     Ipilimumab ADA+ 99999 99999 99999 99999 99999 99999 99999 99999 99999 99999 99999 99999 99999 99999 99999 99999 99999 99999 99999 99999 99999 99999 1
Notes [51] - Only in participants who have baseline and at least 1 post-treatment immunogenicity measurement [52] - Only in participants who have baseline and at least 1 post-treatment immunogenicity measurement [53] - Only in participants who have baseline and at least 1 post-treatment immunogenicity measurement [54] - Only in participants who have baseline and at least 1 post-treatment immunogenicity measurement
No statistical analyses for this end point

Secondary: Number of Participants with a Positive Anti-Drug Antibody (ADA) Test Top of page

Adverse events Top of page
Adverse events information
Timeframe for reporting adverse events	Participants were assessed for All-Cause Mortality from their first dose until the study was completed (up to approximately 5 years and 8 months) SAEs and NSAEs were assessed from first dose to 100 days following last dose (up to approximately 15 months)
Assessment type	Systematic
Dictionary used for adverse event reporting
Dictionary name	MedDRA
Dictionary version	24.1
Reporting groups
Reporting group title	Part 1: BMS50+NIV240(ESC)
Reporting group description	BMS-986205 50mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS25+NIV240(ESC)
Reporting group description	BMS-986205 25mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS400 (ESC)
Reporting group description	BMS-986205 400mg monotherapy. BMS-986205 administered orally in tablet or capsule formulation daily
Reporting group title	Part 1: BMS50 (ESC)
Reporting group description	BMS-986205 50mg monotherapy. BMS-986205 administered orally in tablet or capsule formulation daily
Reporting group title	Part 2: Exp Pancreatic
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS200+NIV240(ESC)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS400+NIV240(ESC)
Reporting group description	BMS-986205 400mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Cervical + (IDO 100)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Cervical + (IDO 200)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 1: BMS100+NIV240(ESC)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Bladder + (IDO 100)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp SCCHN + (IDO 200)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Bladder + (IDO 100)
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp DLBCL
Reporting group description	BMS-986205 100mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Bladder + (IDO 200)
Reporting group description	BMS-986205 200mg + nivolumab 240mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 2 weeks.
Reporting group title	Part 2: Exp Renal
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ASST
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp NSCLC Anti-PDL1
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp NSCLC I-O Naive
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML Anti-PDL1+CTLA4
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML I-O Naive
Reporting group description	BMS-986205 100mg+ nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML BRAF-MT
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML BRAF-MT- NIVO
Reporting group description	Nivolumab 480mg administered as IV infusion once every 4 weeks.
Reporting group title	Part 2: Exp ML Anti-PDL1
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks.
Reporting group title	Food Effect/ Relative BA (FE BA) Substudy
Reporting group description	BMS-986205 100mg + nivolumab 480mg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion.
Reporting group title	Unplanned
Reporting group description	Nivolumab 480mg administered as IV infusion.
Reporting group title	Part 3: NSCLC
Reporting group description	BMS-986205 50mg + nivolumab 360mg + ipilimumab 1mg/kg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 3 weeks. Ipilimumab administered as IV infusion once every 6 weeks.
Reporting group title	Part 3: Melanoma
Reporting group description	BMS-986205 50mg + nivolumab 480mg + ipilimumab 1mg/kg combo therapy. BMS-986205 administered orally in tablet or capsule formulation daily. Nivolumab administered as IV infusion once every 4 weeks. Ipilimumab administered as IV infusion once every 8 weeks.
Reporting group title	QTc Substudy
Reporting group description	BMS-986205 + nivolumab combo therapy. BMS-986205 administered orally daily. Nivolumab administered as IV infusion.
Reporting group title	Unplanned - BMS50
Reporting group description	BMS-986205 50mg administered orally in tablet or capsule formulation.
Serious adverse events Part 1: BMS50+NIV240(ESC) Part 1: BMS25+NIV240(ESC) Part 1: BMS400 (ESC) Part 1: BMS50 (ESC) Part 2: Exp Pancreatic Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 1: BMS100+NIV240(ESC) Part 2: Exp Bladder + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp DLBCL Part 2: Exp Bladder + (IDO 200) Part 2: Exp Renal Part 2: Exp ASST Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp NSCLC I-O Naive Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Food Effect/ Relative BA (FE BA) Substudy Unplanned Part 3: NSCLC Part 3: Melanoma QTc Substudy Unplanned - BMS50 Total subjects affected by serious adverse events      subjects affected / exposed 6 / 10 (60.00%) 5 / 7 (71.43%) 1 / 1 (100.00%) 1 / 1 (100.00%) 18 / 22 (81.82%) 12 / 18 (66.67%) 5 / 6 (83.33%) 15 / 18 (83.33%) 14 / 17 (82.35%) 8 / 12 (66.67%) 12 / 14 (85.71%) 9 / 14 (64.29%) 12 / 15 (80.00%) 27 / 35 (77.14%) 11 / 16 (68.75%) 22 / 42 (52.38%) 22 / 32 (68.75%) 32 / 41 (78.05%) 50 / 80 (62.50%) 10 / 17 (58.82%) 42 / 79 (53.16%) 8 / 9 (88.89%) 1 / 6 (16.67%) 18 / 37 (48.65%) 7 / 14 (50.00%) 1 / 1 (100.00%) 13 / 15 (86.67%) 9 / 26 (34.62%) 14 / 20 (70.00%) 0 / 1 (0.00%)      number of deaths (all causes) 8 6 1 1 21 15 4 16 12 9 9 12 12 21 12 19 22 34 59 12 34 6 2 26 9 0 9 7 14 0      number of deaths resulting from adverse events Neoplasms benign, malignant and unspecified (incl cysts and polyps) Basal cell carcinoma      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 3 / 79 (3.80%) 0 / 9 (0.00%) 1 / 6 (16.67%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 5 0 / 0 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Breast cancer      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cancer pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 1 / 32 (3.13%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 2 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Colon cancer      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Endometrial cancer      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Invasive lobular breast carcinoma      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Lentigo maligna      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Malignant melanoma      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Malignant neoplasm progression      subjects affected / exposed 5 / 10 (50.00%) 3 / 7 (42.86%) 0 / 1 (0.00%) 1 / 1 (100.00%) 15 / 22 (68.18%) 6 / 18 (33.33%) 2 / 6 (33.33%) 8 / 18 (44.44%) 2 / 17 (11.76%) 4 / 12 (33.33%) 4 / 14 (28.57%) 3 / 14 (21.43%) 6 / 15 (40.00%) 11 / 35 (31.43%) 8 / 16 (50.00%) 4 / 42 (9.52%) 10 / 32 (31.25%) 15 / 41 (36.59%) 22 / 80 (27.50%) 5 / 17 (29.41%) 11 / 79 (13.92%) 3 / 9 (33.33%) 0 / 6 (0.00%) 7 / 37 (18.92%) 3 / 14 (21.43%) 0 / 1 (0.00%) 2 / 15 (13.33%) 3 / 26 (11.54%) 8 / 20 (40.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 5 0 / 3 0 / 0 0 / 1 0 / 15 0 / 6 0 / 2 0 / 8 0 / 2 0 / 4 0 / 4 0 / 3 0 / 6 0 / 13 0 / 8 0 / 4 0 / 10 0 / 16 0 / 24 0 / 5 0 / 12 0 / 3 0 / 0 0 / 7 0 / 3 0 / 0 0 / 2 0 / 3 0 / 8 0 / 0      deaths causally related to treatment / all 0 / 5 0 / 2 0 / 0 0 / 1 0 / 15 0 / 6 0 / 2 0 / 7 0 / 2 0 / 4 0 / 4 0 / 3 0 / 6 0 / 10 0 / 8 0 / 2 0 / 9 0 / 11 0 / 22 0 / 5 0 / 9 0 / 3 0 / 0 0 / 7 0 / 3 0 / 0 0 / 1 0 / 1 0 / 8 0 / 0 Metastases to central nervous system      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Metastases to gallbladder      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Metastatic malignant melanoma      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Neoplasm progression      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Prostate cancer      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Recurrent cancer      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Squamous cell carcinoma      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Squamous cell carcinoma of skin      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Tumour haemorrhage      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Tumour pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 2 / 20 (10.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 Vascular disorders Aortic aneurysm rupture      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 Deep vein thrombosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Embolism      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Haematoma      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hypotension      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Jugular vein thrombosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Phlebitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Shock      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Superior vena cava syndrome      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Venous thrombosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 General disorders and administration site conditions Asthenia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Chest pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Fatigue      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 General physical health deterioration      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 4 / 80 (5.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 1 / 9 (11.11%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 5 0 / 0 0 / 1 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hyperthermia malignant      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Malaise      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Mucosal inflammation      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Non-cardiac chest pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Oedema peripheral      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Performance status decreased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Peripheral swelling      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pyrexia      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 1 / 18 (5.56%) 1 / 17 (5.88%) 0 / 12 (0.00%) 1 / 14 (7.14%) 1 / 14 (7.14%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 2 / 41 (4.88%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 1 / 9 (11.11%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 1 0 / 1 0 / 0 0 / 1 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 1 / 1 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 1 / 1 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Immune system disorders Haemophagocytic lymphohistiocytosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Sarcoidosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Reproductive system and breast disorders Female genital tract fistula      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory, thoracic and mediastinal disorders Acute respiratory failure      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 2 / 14 (14.29%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Bronchial obstruction      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Bronchospasm      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Chronic obstructive pulmonary disease      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Diaphragmatic paralysis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Dyspnoea      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 2 / 17 (11.76%) 0 / 12 (0.00%) 1 / 14 (7.14%) 2 / 14 (14.29%) 0 / 15 (0.00%) 2 / 35 (5.71%) 1 / 16 (6.25%) 2 / 42 (4.76%) 4 / 32 (12.50%) 5 / 41 (12.20%) 5 / 80 (6.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 4 / 15 (26.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 2 0 / 0 0 / 1 0 / 2 0 / 0 0 / 2 0 / 1 0 / 2 0 / 4 0 / 6 1 / 6 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 4 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 Haemoptysis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 1 / 17 (5.88%) 0 / 12 (0.00%) 1 / 14 (7.14%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 1 0 / 0 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hypoxia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 2 / 41 (4.88%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pleural effusion      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 2 / 42 (4.76%) 2 / 32 (6.25%) 1 / 41 (2.44%) 2 / 80 (2.50%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 3 0 / 2 0 / 1 0 / 2 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 2 / 41 (4.88%) 4 / 80 (5.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 2 4 / 4 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pneumothorax      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 3 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Productive cough      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pulmonary embolism      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 2 / 22 (9.09%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 2 / 42 (4.76%) 1 / 32 (3.13%) 7 / 41 (17.07%) 2 / 80 (2.50%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 2 / 20 (10.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 2 0 / 1 1 / 7 0 / 2 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pulmonary mass      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pulmonary oedema      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory distress      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory failure      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 1 / 1 (100.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 1 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Psychiatric disorders Anxiety      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Behaviour disorder      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Confusional state      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Delirium      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Mental status changes      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Investigations Blood bilirubin increased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 2 / 22 (9.09%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Blood creatinine increased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Liver function test increased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Transaminases increased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 1 / 1 (100.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 1 / 1 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Injury, poisoning and procedural complications Accidental overdose      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Acetabulum fracture      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Arterial injury      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Extradural haematoma      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Femur fracture      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Haemolytic transfusion reaction      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hip fracture      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Humerus fracture      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Infusion related reaction      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pelvic fracture      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Post procedural complication      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Rib fracture      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Spinal fracture      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Subdural haematoma      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Tracheal haemorrhage      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Congenital, familial and genetic disorders Tracheo-oesophageal fistula      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cardiac disorders Acute coronary syndrome      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Acute myocardial infarction      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Atrial fibrillation      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Atrial flutter      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cardiac arrest      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cardiac failure      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cardiac failure acute      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cardiac tamponade      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cardiac valve disease      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cardio-respiratory arrest      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 Cardiomyopathy      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Coronary artery disease      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Coronary artery perforation      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Myocardial infarction      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 2 / 32 (6.25%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 3 0 / 0 0 / 2 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Myocarditis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pericardial effusion      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 2 / 17 (11.76%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pericarditis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Sinus tachycardia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Tachycardia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Nervous system disorders Brain oedema      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cauda equina syndrome      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Central nervous system lesion      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cerebral haemorrhage      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Depressed level of consciousness      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Dizziness      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Dysaesthesia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Dysarthria      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Facial paralysis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Guillain-Barre syndrome      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Haemorrhage intracranial      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Headache      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hemiparesis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hemiplegia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Intracranial haematoma      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Ischaemic stroke      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Meningism      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Migraine with aura      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Monoparesis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Neuralgic amyotrophy      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Paraesthesia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Seizure      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Simple partial seizures      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Spinal cord compression      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Syncope      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Transient ischaemic attack      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Blood and lymphatic system disorders Anaemia      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 1 / 42 (2.38%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 1 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Febrile bone marrow aplasia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 2 / 35 (5.71%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Febrile neutropenia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 2 / 35 (5.71%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Haemolytic anaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Neutropenia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 2 / 35 (5.71%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 3 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Splenic infarction      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Thrombocytopenia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Eye disorders Diplopia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Visual acuity reduced      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Visual impairment      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastrointestinal disorders Abdominal pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 3 / 22 (13.64%) 1 / 18 (5.56%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 2 / 32 (6.25%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 2 / 14 (14.29%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 4 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Abdominal pain upper      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Abdominal pain lower      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Ascites      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 2 / 18 (11.11%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 2 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Chronic gastritis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Colitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 1 / 1 0 / 0 4 / 4 0 / 0 0 / 0 0 / 0 0 / 0 1 / 2 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Constipation      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 2 / 18 (11.11%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Diarrhoea      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Dysphagia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastritis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastroduodenal ulcer      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastrointestinal haemorrhage      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastrointestinal obstruction      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Immune-mediated enterocolitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Intestinal obstruction      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 1 / 18 (5.56%) 0 / 6 (0.00%) 1 / 18 (5.56%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 2 0 / 0 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Intra-abdominal haemorrhage      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Large intestinal obstruction      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Lower gastrointestinal haemorrhage      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Nausea      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 2 / 12 (16.67%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Obstruction gastric      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pancreatitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pancreatitis acute      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Small intestinal obstruction      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Small intestinal haemorrhage      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Small intestinal perforation      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Subileus      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Vomiting      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 2 / 41 (4.88%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 2 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hepatobiliary disorders Autoimmune hepatitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 1 / 1 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 1 / 1 2 / 2 0 / 0 0 / 0 0 / 0 2 / 2 0 / 0 1 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cholangitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cholecystitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cholelithiasis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Drug-induced liver injury      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hepatic failure      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hepatitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hepatitis cholestatic      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hyperbilirubinaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Immune-mediated hepatitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 2 / 15 (13.33%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 3 / 3 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 2 / 2 1 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Jaundice cholestatic      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 1 / 1 (100.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Liver injury      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Skin and subcutaneous tissue disorders Drug reaction with eosinophilia and systemic symptoms      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Rash      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Rash maculo-papular      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Stevens-Johnson syndrome      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Renal and urinary disorders Acute kidney injury      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 1 / 1 (100.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Haematuria      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 1 / 1 (100.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hydronephrosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Oliguria      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Renal failure      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Renal tubular acidosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Urinary bladder polyp      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Urinary retention      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Urinary tract obstruction      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Endocrine disorders Adrenal haemorrhage      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Adrenal insufficiency      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hypophysitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 2 / 2 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Lymphocytic hypophysitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hypothyroidism      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Musculoskeletal and connective tissue disorders Arthralgia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Back pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Bone pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Muscular weakness      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Musculoskeletal chest pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Osteonecrosis of jaw      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pathological fracture      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Sacral pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Synovial cyst      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Infections and infestations Abdominal infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Bacteraemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Bacterial sepsis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Biliary tract infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Bronchitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 2 / 41 (4.88%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 4 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Bronchitis viral      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Cellulitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Device related infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Empyema      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Encephalitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Escherichia urinary tract infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gastroenteritis viral      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Herpes zoster      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Influenza      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Lower respiratory tract infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Mastoiditis      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Osteomyelitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Peritonitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonia      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 3 / 15 (20.00%) 2 / 35 (5.71%) 0 / 16 (0.00%) 2 / 42 (4.76%) 0 / 32 (0.00%) 3 / 41 (7.32%) 7 / 80 (8.75%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 1 0 / 3 0 / 2 0 / 0 0 / 2 0 / 0 0 / 3 0 / 11 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonia aspiration      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 2 / 14 (14.29%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pneumonia respiratory syncytial viral      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Prostatic abscess      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Pyelonephritis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Respiratory tract infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Sepsis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Septic shock      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Skin infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Soft tissue infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Staphylococcal infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Upper respiratory tract infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 3 / 80 (3.75%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 3 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Urinary tract candidiasis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Urinary tract infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 1 / 1 (100.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 2 / 17 (11.76%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 2 0 / 0 0 / 0 0 / 2 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 2 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Urosepsis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Varicella      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Vestibular neuronitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Viral upper respiratory tract infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Wound infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Metabolism and nutrition disorders Cachexia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Decreased appetite      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Dehydration      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Diabetic ketoacidosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Diabetic metabolic decompensation      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Failure to thrive      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Gout      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hypercalcaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 2 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hyperglycaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hypernatraemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hypocalcaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hypokalaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hypomagnesaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hyponatraemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 1 / 1 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 1 / 2 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 1 / 1 0 / 0 0 / 1 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Hypophagia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Malnutrition      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 Steroid diabetes      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 1 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0      deaths causally related to treatment / all 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0 0 / 0
Frequency threshold for reporting non-serious adverse events: 5%
Non-serious adverse events Part 1: BMS50+NIV240(ESC) Part 1: BMS25+NIV240(ESC) Part 1: BMS400 (ESC) Part 1: BMS50 (ESC) Part 2: Exp Pancreatic Part 1: BMS200+NIV240(ESC) Part 1: BMS400+NIV240(ESC) Part 2: Exp Cervical + (IDO 100) Part 2: Exp Cervical + (IDO 200) Part 1: BMS100+NIV240(ESC) Part 2: Exp Bladder + (IDO 100) Part 2: Exp SCCHN + (IDO 200) Part 2: Exp Bladder + (IDO 100) Part 2: Exp DLBCL Part 2: Exp Bladder + (IDO 200) Part 2: Exp Renal Part 2: Exp ASST Part 2: Exp NSCLC Anti-PDL1 Part 2: Exp NSCLC I-O Naive Part 2: Exp ML Anti-PDL1+CTLA4 Part 2: Exp ML I-O Naive Part 2: Exp ML BRAF-MT Part 2: Exp ML BRAF-MT- NIVO Part 2: Exp ML Anti-PDL1 Food Effect/ Relative BA (FE BA) Substudy Unplanned Part 3: NSCLC Part 3: Melanoma QTc Substudy Unplanned - BMS50 Total subjects affected by non serious adverse events      subjects affected / exposed 10 / 10 (100.00%) 7 / 7 (100.00%) 0 / 1 (0.00%) 1 / 1 (100.00%) 20 / 22 (90.91%) 18 / 18 (100.00%) 6 / 6 (100.00%) 18 / 18 (100.00%) 17 / 17 (100.00%) 12 / 12 (100.00%) 14 / 14 (100.00%) 14 / 14 (100.00%) 13 / 15 (86.67%) 29 / 35 (82.86%) 15 / 16 (93.75%) 40 / 42 (95.24%) 30 / 32 (93.75%) 38 / 41 (92.68%) 78 / 80 (97.50%) 17 / 17 (100.00%) 79 / 79 (100.00%) 8 / 9 (88.89%) 6 / 6 (100.00%) 35 / 37 (94.59%) 13 / 14 (92.86%) 1 / 1 (100.00%) 14 / 15 (93.33%) 26 / 26 (100.00%) 19 / 20 (95.00%) 0 / 1 (0.00%) Neoplasms benign, malignant and unspecified (incl cysts and polyps) Cancer pain      subjects affected / exposed 1 / 10 (10.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 1 / 80 (1.25%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 1 / 26 (3.85%) 2 / 20 (10.00%) 0 / 1 (0.00%)      occurrences all number 1 1 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 1 1 0 0 0 0 0 0 1 1 2 0 Cervix cancer metastatic      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Infected neoplasm      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Malignant neoplasm progression      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 2 / 15 (13.33%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 4 0 0 0 0 0 0 0 2 0 0 0 Skin papilloma      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Tumour exudation      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Tumour pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 2 / 17 (11.76%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 2 1 0 0 1 1 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 Vascular disorders Deep vein thrombosis      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 2 / 22 (9.09%) 2 / 18 (11.11%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 2 / 12 (16.67%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 1 / 32 (3.13%) 4 / 41 (9.76%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 2 / 9 (22.22%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 2 2 0 0 0 2 0 0 1 0 1 0 1 4 1 0 0 3 0 1 0 0 0 1 1 0 Embolism      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Flushing      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 1 0 0 0 0 0 0 Hot flush      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 1 / 18 (5.56%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 2 / 35 (5.71%) 1 / 16 (6.25%) 1 / 42 (2.38%) 4 / 32 (12.50%) 0 / 41 (0.00%) 4 / 80 (5.00%) 0 / 17 (0.00%) 4 / 79 (5.06%) 0 / 9 (0.00%) 1 / 6 (16.67%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 1 1 0 1 0 0 0 0 1 2 1 1 4 0 4 0 4 0 1 2 0 0 0 3 0 0 Haemorrhage      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 Haematoma      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 Hypertension      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 1 / 18 (5.56%) 0 / 6 (0.00%) 3 / 18 (16.67%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 2 / 15 (13.33%) 1 / 35 (2.86%) 0 / 16 (0.00%) 4 / 42 (9.52%) 0 / 32 (0.00%) 2 / 41 (4.88%) 3 / 80 (3.75%) 0 / 17 (0.00%) 6 / 79 (7.59%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 1 0 3 0 0 1 0 2 1 0 4 0 2 3 0 8 0 1 0 0 0 0 0 0 0 Hypotension      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 2 / 18 (11.11%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 2 / 42 (4.76%) 2 / 32 (6.25%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 2 / 79 (2.53%) 1 / 9 (11.11%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 1 2 0 1 0 0 0 1 0 0 1 2 2 1 1 0 3 1 0 2 0 0 0 2 0 0 Lymphoedema      subjects affected / exposed 2 / 10 (20.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 2 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 1 0 0 0 0 0 0 Orthostatic hypotension      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 Superior vena cava syndrome      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Venous thrombosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 General disorders and administration site conditions Asthenia      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 2 / 22 (9.09%) 0 / 18 (0.00%) 0 / 6 (0.00%) 3 / 18 (16.67%) 0 / 17 (0.00%) 0 / 12 (0.00%) 4 / 14 (28.57%) 0 / 14 (0.00%) 4 / 15 (26.67%) 8 / 35 (22.86%) 1 / 16 (6.25%) 3 / 42 (7.14%) 9 / 32 (28.13%) 7 / 41 (17.07%) 13 / 80 (16.25%) 2 / 17 (11.76%) 10 / 79 (12.66%) 3 / 9 (33.33%) 1 / 6 (16.67%) 6 / 37 (16.22%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 2 0 0 3 0 0 4 0 4 8 1 4 10 7 15 2 12 6 1 6 0 0 0 1 0 0 Axillary pain      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 1 / 32 (3.13%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 1 1 1 0 2 0 0 1 0 0 0 0 0 0 Catheter site pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 Chest discomfort      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 4 / 26 (15.38%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 0 0 5 0 0 Chills      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 2 / 18 (11.11%) 0 / 6 (0.00%) 0 / 18 (0.00%) 2 / 17 (11.76%) 2 / 12 (16.67%) 1 / 14 (7.14%) 0 / 14 (0.00%) 1 / 15 (6.67%) 1 / 35 (2.86%) 1 / 16 (6.25%) 2 / 42 (4.76%) 2 / 32 (6.25%) 0 / 41 (0.00%) 4 / 80 (5.00%) 1 / 17 (5.88%) 6 / 79 (7.59%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 1 / 1 (100.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 2 0 0 2 3 1 0 1 1 1 2 2 0 4 1 7 0 1 0 0 1 0 0 0 0 Cyst      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Device related thrombosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Early satiety      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Facial pain      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 General physical health deterioration      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 2 0 0 2 0 0 0 0 0 0 0 0 Gait disturbance      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 Fatigue      subjects affected / exposed 7 / 10 (70.00%) 4 / 7 (57.14%) 0 / 1 (0.00%) 0 / 1 (0.00%) 6 / 22 (27.27%) 12 / 18 (66.67%) 4 / 6 (66.67%) 5 / 18 (27.78%) 9 / 17 (52.94%) 7 / 12 (58.33%) 3 / 14 (21.43%) 6 / 14 (42.86%) 3 / 15 (20.00%) 1 / 35 (2.86%) 7 / 16 (43.75%) 18 / 42 (42.86%) 13 / 32 (40.63%) 13 / 41 (31.71%) 23 / 80 (28.75%) 5 / 17 (29.41%) 32 / 79 (40.51%) 1 / 9 (11.11%) 3 / 6 (50.00%) 9 / 37 (24.32%) 9 / 14 (64.29%) 0 / 1 (0.00%) 8 / 15 (53.33%) 16 / 26 (61.54%) 5 / 20 (25.00%) 0 / 1 (0.00%)      occurrences all number 7 4 0 0 6 14 5 5 10 10 3 6 3 1 9 21 13 14 24 5 34 1 3 10 9 0 10 17 5 0 Hyperthermia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 Influenza like illness      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 1 / 41 (2.44%) 2 / 80 (2.50%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 2 / 6 (33.33%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 4 / 26 (15.38%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 2 2 0 3 0 2 1 0 0 0 4 0 0 Inflammation      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 2 / 35 (5.71%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Illness      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Non-cardiac chest pain      subjects affected / exposed 2 / 10 (20.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 1 / 14 (7.14%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 4 / 42 (9.52%) 1 / 32 (3.13%) 6 / 41 (14.63%) 2 / 80 (2.50%) 1 / 17 (5.88%) 5 / 79 (6.33%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 2 0 0 0 1 0 1 0 0 1 1 0 1 0 0 4 1 7 2 1 5 0 0 2 0 0 0 2 0 0 Nodule      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 1 0 Mucosal inflammation      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 3 1 0 0 0 1 0 0 0 0 0 0 Oedema peripheral      subjects affected / exposed 1 / 10 (10.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 1 / 1 (100.00%) 3 / 22 (13.64%) 4 / 18 (22.22%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 1 / 12 (8.33%) 1 / 14 (7.14%) 3 / 14 (21.43%) 1 / 15 (6.67%) 1 / 35 (2.86%) 2 / 16 (12.50%) 7 / 42 (16.67%) 7 / 32 (21.88%) 3 / 41 (7.32%) 7 / 80 (8.75%) 0 / 17 (0.00%) 5 / 79 (6.33%) 2 / 9 (22.22%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 3 / 26 (11.54%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 1 0 1 3 5 0 0 1 1 1 3 1 1 2 10 7 3 9 0 6 2 0 2 0 0 0 3 0 0 Pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 2 / 12 (16.67%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 2 / 42 (4.76%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 2 0 0 1 0 4 0 0 0 0 0 1 0 0 0 Performance status decreased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 1 / 1 (100.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 Peripheral swelling      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 2 / 18 (11.11%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 3 / 79 (3.80%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 2 0 0 0 0 0 0 0 0 0 1 1 0 0 0 3 0 0 1 0 0 0 0 0 0 Physical deconditioning      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 Puncture site haematoma      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 Pyrexia      subjects affected / exposed 1 / 10 (10.00%) 2 / 7 (28.57%) 0 / 1 (0.00%) 0 / 1 (0.00%) 6 / 22 (27.27%) 4 / 18 (22.22%) 0 / 6 (0.00%) 1 / 18 (5.56%) 3 / 17 (17.65%) 3 / 12 (25.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 2 / 15 (13.33%) 4 / 35 (11.43%) 4 / 16 (25.00%) 7 / 42 (16.67%) 7 / 32 (21.88%) 2 / 41 (4.88%) 8 / 80 (10.00%) 2 / 17 (11.76%) 8 / 79 (10.13%) 3 / 9 (33.33%) 0 / 6 (0.00%) 2 / 37 (5.41%) 1 / 14 (7.14%) 0 / 1 (0.00%) 4 / 15 (26.67%) 6 / 26 (23.08%) 3 / 20 (15.00%) 0 / 1 (0.00%)      occurrences all number 1 3 0 0 6 4 0 1 3 3 1 0 2 6 4 11 10 4 8 2 8 4 0 2 1 0 6 7 3 0 Suprapubic pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 Swelling      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 2 0 0 Temperature intolerance      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 Swelling face      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Immune system disorders Amyloidosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 Contrast media allergy      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 2 0 0 0 0 0 0 0 0 0 Contrast media reaction      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 Seasonal allergy      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 4 / 79 (5.06%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 5 0 0 0 0 0 0 0 0 0 Hypersensitivity      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 1 0 1 0 0 0 1 0 0 0 Drug hypersensitivity      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 2 0 0 0 0 0 0 0 0 Reproductive system and breast disorders Female genital tract fistula      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Pelvic pain      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 2 / 16 (12.50%) 2 / 42 (4.76%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 0 0 1 0 1 0 0 0 0 4 2 1 0 0 0 0 0 0 0 1 0 0 0 0 0 Pelvic haemorrhage      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Penile pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Prostatitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 Vaginal discharge      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 Vaginal haemorrhage      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 1 / 18 (5.56%) 2 / 17 (11.76%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 3 0 1 2 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 Vulvovaginal pruritus      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Respiratory, thoracic and mediastinal disorders Asthma      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 Atelectasis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Bronchial obstruction      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 0 0 Bronchostenosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Dyspnoea      subjects affected / exposed 2 / 10 (20.00%) 3 / 7 (42.86%) 0 / 1 (0.00%) 0 / 1 (0.00%) 3 / 22 (13.64%) 2 / 18 (11.11%) 2 / 6 (33.33%) 4 / 18 (22.22%) 2 / 17 (11.76%) 2 / 12 (16.67%) 2 / 14 (14.29%) 0 / 14 (0.00%) 4 / 15 (26.67%) 4 / 35 (11.43%) 0 / 16 (0.00%) 7 / 42 (16.67%) 11 / 32 (34.38%) 11 / 41 (26.83%) 19 / 80 (23.75%) 1 / 17 (5.88%) 12 / 79 (15.19%) 0 / 9 (0.00%) 0 / 6 (0.00%) 4 / 37 (10.81%) 1 / 14 (7.14%) 0 / 1 (0.00%) 2 / 15 (13.33%) 5 / 26 (19.23%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 2 3 0 0 3 2 2 4 2 3 2 0 4 4 0 9 11 13 22 1 13 0 0 4 1 0 3 7 1 0 Dysphonia      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 1 / 16 (6.25%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 4 / 79 (5.06%) 0 / 9 (0.00%) 0 / 6 (0.00%) 3 / 37 (8.11%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 2 / 20 (10.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 1 0 0 0 1 0 0 0 0 1 1 1 0 0 2 0 4 0 0 3 0 0 0 0 2 0 Cough      subjects affected / exposed 2 / 10 (20.00%) 2 / 7 (28.57%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 5 / 18 (27.78%) 1 / 6 (16.67%) 2 / 18 (11.11%) 5 / 17 (29.41%) 2 / 12 (16.67%) 0 / 14 (0.00%) 2 / 14 (14.29%) 4 / 15 (26.67%) 1 / 35 (2.86%) 1 / 16 (6.25%) 7 / 42 (16.67%) 9 / 32 (28.13%) 11 / 41 (26.83%) 21 / 80 (26.25%) 1 / 17 (5.88%) 16 / 79 (20.25%) 2 / 9 (22.22%) 2 / 6 (33.33%) 8 / 37 (21.62%) 1 / 14 (7.14%) 0 / 1 (0.00%) 1 / 15 (6.67%) 6 / 26 (23.08%) 5 / 20 (25.00%) 0 / 1 (0.00%)      occurrences all number 2 2 0 0 1 5 1 2 7 2 0 2 4 1 2 7 9 12 22 1 20 2 3 11 1 0 1 7 5 0 Dyspnoea exertional      subjects affected / exposed 2 / 10 (20.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 1 / 15 (6.67%) 1 / 35 (2.86%) 1 / 16 (6.25%) 0 / 42 (0.00%) 2 / 32 (6.25%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 3 / 79 (3.80%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 3 / 20 (15.00%) 0 / 1 (0.00%)      occurrences all number 2 0 0 0 1 0 0 0 1 0 0 1 2 1 1 0 2 1 0 0 3 0 0 0 1 0 0 0 3 0 Epistaxis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 1 0 0 1 0 2 0 0 3 0 0 0 1 0 0 Haemoptysis      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 1 / 12 (8.33%) 2 / 14 (14.29%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 6 / 80 (7.50%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 3 / 37 (8.11%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 2 1 2 0 1 0 0 0 0 1 7 0 0 0 0 3 0 0 1 0 0 0 Hiccups      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Hypoxia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 1 0 0 2 1 0 0 0 0 0 1 0 0 Lung consolidation      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Lung disorder      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Oropharyngeal pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 2 / 12 (16.67%) 1 / 14 (7.14%) 1 / 14 (7.14%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 2 / 42 (4.76%) 0 / 32 (0.00%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 1 / 6 (16.67%) 2 / 37 (5.41%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 4 / 26 (15.38%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 2 1 1 1 0 0 3 0 1 1 0 2 0 1 2 1 0 0 5 0 0 Painful respiration      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Nasal congestion      subjects affected / exposed 0 / 10 (0.00%) 2 / 7 (28.57%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 2 / 42 (4.76%) 1 / 32 (3.13%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 3 / 79 (3.80%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 2 0 0 0 1 0 0 0 0 0 1 0 0 0 2 1 1 1 0 3 0 0 1 0 0 0 0 0 0 Paranasal sinus hypersecretion      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Pneumonitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 3 / 42 (7.14%) 1 / 32 (3.13%) 2 / 41 (4.88%) 4 / 80 (5.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 4 1 2 5 0 1 0 0 2 0 0 0 2 0 0 Pleuritic pain      subjects affected / exposed 1 / 10 (10.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 2 / 41 (4.88%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 2 0 0 Pleural effusion      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 3 / 14 (21.43%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 2 / 32 (6.25%) 2 / 41 (4.88%) 6 / 80 (7.50%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 2 / 20 (10.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 1 0 3 0 1 0 0 2 2 7 0 0 0 0 1 1 0 0 2 3 0 Pneumothorax      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 Productive cough      subjects affected / exposed 1 / 10 (10.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 1 / 15 (6.67%) 2 / 35 (5.71%) 0 / 16 (0.00%) 2 / 42 (4.76%) 0 / 32 (0.00%) 2 / 41 (4.88%) 2 / 80 (2.50%) 1 / 17 (5.88%) 3 / 79 (3.80%) 1 / 9 (11.11%) 0 / 6 (0.00%) 3 / 37 (8.11%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 1 0 0 0 0 0 0 0 0 1 0 1 3 0 3 0 2 2 1 4 2 0 3 1 0 0 3 0 0 Rhinorrhoea      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 Pulmonary embolism      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 2 / 22 (9.09%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 3 / 42 (7.14%) 1 / 32 (3.13%) 4 / 41 (9.76%) 3 / 80 (3.75%) 0 / 17 (0.00%) 2 / 79 (2.53%) 1 / 9 (11.11%) 0 / 6 (0.00%) 1 / 37 (2.70%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 2 0 0 1 0 1 0 0 0 0 1 3 1 4 3 0 2 1 0 1 1 0 0 1 0 0 Sinus pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Sinus congestion      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 Stridor      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Wheezing      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 4 / 80 (5.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 4 0 0 0 0 0 1 0 0 0 0 0 Upper-airway cough syndrome      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 1 0 1 0 0 0 0 0 0 0 0 0 Psychiatric disorders Agitation      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 Anxiety      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 1 / 18 (5.56%) 0 / 6 (0.00%) 1 / 18 (5.56%) 1 / 17 (5.88%) 2 / 12 (16.67%) 1 / 14 (7.14%) 1 / 14 (7.14%) 0 / 15 (0.00%) 2 / 35 (5.71%) 0 / 16 (0.00%) 1 / 42 (2.38%) 3 / 32 (9.38%) 0 / 41 (0.00%) 4 / 80 (5.00%) 0 / 17 (0.00%) 6 / 79 (7.59%) 0 / 9 (0.00%) 1 / 6 (16.67%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 1 0 1 1 2 1 1 0 2 0 1 3 0 4 0 6 0 1 2 0 0 0 1 0 0 Depressed mood      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 1 0 0 0 0 0 1 0 0 0 Delirium      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Confusional state      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 1 / 18 (5.56%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 1 1 1 0 0 0 0 0 2 0 0 0 1 0 2 0 1 0 0 0 0 0 0 0 0 0 Depression      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 4 / 42 (9.52%) 1 / 32 (3.13%) 3 / 41 (7.32%) 1 / 80 (1.25%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 4 1 3 1 0 2 0 1 0 1 0 0 0 0 0 Mental status changes      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 Insomnia      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 3 / 22 (13.64%) 2 / 18 (11.11%) 0 / 6 (0.00%) 0 / 18 (0.00%) 3 / 17 (17.65%) 2 / 12 (16.67%) 2 / 14 (14.29%) 1 / 14 (7.14%) 1 / 15 (6.67%) 0 / 35 (0.00%) 1 / 16 (6.25%) 2 / 42 (4.76%) 3 / 32 (9.38%) 2 / 41 (4.88%) 5 / 80 (6.25%) 1 / 17 (5.88%) 10 / 79 (12.66%) 0 / 9 (0.00%) 0 / 6 (0.00%) 5 / 37 (13.51%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 3 / 26 (11.54%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 3 3 0 0 3 2 2 1 1 0 1 2 3 2 5 1 13 0 0 5 0 0 0 3 1 0 Hallucination      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 1 0 0 1 1 0 0 0 0 0 0 0 0 0 Restlessness      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Phonophobia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Mood altered      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 0 0 Sleep disorder      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 Product issues Device occlusion      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Investigations Alanine aminotransferase increased      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 3 / 22 (13.64%) 3 / 18 (16.67%) 1 / 6 (16.67%) 1 / 18 (5.56%) 6 / 17 (35.29%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 1 / 15 (6.67%) 2 / 35 (5.71%) 3 / 16 (18.75%) 4 / 42 (9.52%) 6 / 32 (18.75%) 8 / 41 (19.51%) 13 / 80 (16.25%) 0 / 17 (0.00%) 12 / 79 (15.19%) 1 / 9 (11.11%) 0 / 6 (0.00%) 4 / 37 (10.81%) 0 / 14 (0.00%) 1 / 1 (100.00%) 7 / 15 (46.67%) 4 / 26 (15.38%) 4 / 20 (20.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 4 3 1 1 7 0 2 0 1 2 3 4 6 11 15 0 15 1 0 5 0 1 10 5 5 0 Amylase increased      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 2 / 18 (11.11%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 2 / 14 (14.29%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 1 / 16 (6.25%) 3 / 42 (7.14%) 1 / 32 (3.13%) 2 / 41 (4.88%) 2 / 80 (2.50%) 2 / 17 (11.76%) 4 / 79 (5.06%) 1 / 9 (11.11%) 0 / 6 (0.00%) 1 / 37 (2.70%) 1 / 14 (7.14%) 0 / 1 (0.00%) 2 / 15 (13.33%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 2 0 0 0 0 7 0 0 1 1 3 1 2 2 2 6 3 0 1 1 0 6 2 0 0 Aspartate aminotransferase increased      subjects affected / exposed 2 / 10 (20.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 3 / 22 (13.64%) 4 / 18 (22.22%) 0 / 6 (0.00%) 1 / 18 (5.56%) 5 / 17 (29.41%) 1 / 12 (8.33%) 1 / 14 (7.14%) 0 / 14 (0.00%) 2 / 15 (13.33%) 4 / 35 (11.43%) 3 / 16 (18.75%) 4 / 42 (9.52%) 5 / 32 (15.63%) 8 / 41 (19.51%) 10 / 80 (12.50%) 0 / 17 (0.00%) 13 / 79 (16.46%) 2 / 9 (22.22%) 0 / 6 (0.00%) 4 / 37 (10.81%) 0 / 14 (0.00%) 1 / 1 (100.00%) 6 / 15 (40.00%) 2 / 26 (7.69%) 4 / 20 (20.00%) 0 / 1 (0.00%)      occurrences all number 3 1 0 0 4 4 0 1 5 1 2 0 4 4 4 4 5 10 14 0 15 3 0 4 0 1 12 2 4 0 Blood albumin decreased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 2 / 32 (6.25%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 1 0 0 0 Blood alkaline phosphatase increased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 2 / 35 (5.71%) 2 / 16 (12.50%) 0 / 42 (0.00%) 3 / 32 (9.38%) 0 / 41 (0.00%) 3 / 80 (3.75%) 0 / 17 (0.00%) 2 / 79 (2.53%) 2 / 9 (22.22%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 2 / 15 (13.33%) 1 / 26 (3.85%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 0 0 0 1 0 0 0 0 2 2 0 3 0 3 0 2 2 0 1 0 0 3 1 1 0 Blood bilirubin increased      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 4 / 22 (18.18%) 2 / 18 (11.11%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 3 / 14 (21.43%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 2 / 32 (6.25%) 1 / 41 (2.44%) 3 / 80 (3.75%) 0 / 17 (0.00%) 4 / 79 (5.06%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 4 2 0 0 0 0 0 4 0 0 0 3 2 3 3 0 4 0 0 1 0 0 2 1 0 0 Blood calcium increased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 Blood creatine phosphokinase increased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 1 / 1 (100.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 1 0 0 0 0 1 0 0 0 0 Blood creatinine increased      subjects affected / exposed 1 / 10 (10.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 2 / 18 (11.11%) 2 / 17 (11.76%) 0 / 12 (0.00%) 2 / 14 (14.29%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 1 / 16 (6.25%) 2 / 42 (4.76%) 0 / 32 (0.00%) 3 / 41 (7.32%) 3 / 80 (3.75%) 0 / 17 (0.00%) 1 / 79 (1.27%) 1 / 9 (11.11%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 2 / 26 (7.69%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 1 1 0 0 0 0 0 3 3 0 2 0 0 1 1 3 0 5 4 0 1 2 1 0 0 0 1 2 1 0 Blood glucose increased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Blood lactate dehydrogenase increased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 2 / 41 (4.88%) 1 / 80 (1.25%) 0 / 17 (0.00%) 3 / 79 (3.80%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 2 1 0 3 1 0 0 0 0 1 0 1 0 Blood magnesium decreased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 Blood methaemoglobin present      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 2 / 20 (10.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 1 0 0 0 0 2 0 0 0 0 0 0 0 2 0 C-reactive protein increased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 Blood thyroid stimulating hormone increased      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 Blood thyroid stimulating hormone decreased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 Electrocardiogram QT prolonged      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 Haptoglobin increased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Haptoglobin decreased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Gamma-glutamyltransferase increased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 2 / 32 (6.25%) 2 / 41 (4.88%) 5 / 80 (6.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 2 / 37 (5.41%) 1 / 14 (7.14%) 0 / 1 (0.00%) 3 / 15 (20.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 2 2 5 0 1 0 0 2 1 0 4 0 0 0 Hepatic enzyme increased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 2 0 1 0 0 0 0 0 0 0 0 0 International normalised ratio fluctuation      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Lipase increased      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 1 / 15 (6.67%) 1 / 35 (2.86%) 1 / 16 (6.25%) 5 / 42 (11.90%) 1 / 32 (3.13%) 1 / 41 (2.44%) 4 / 80 (5.00%) 2 / 17 (11.76%) 4 / 79 (5.06%) 1 / 9 (11.11%) 1 / 6 (16.67%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 4 / 15 (26.67%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 2 0 0 0 0 1 0 0 0 0 8 0 1 1 2 6 1 1 4 2 6 1 1 1 0 0 9 1 0 0 Lymphocyte count decreased      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 1 / 9 (11.11%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 2 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 2 0 0 0 2 1 0 1 0 0 0 0 0 0 Neutrophil count decreased      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 0 2 0 2 0 1 0 0 0 0 0 3 0 0 0 1 0 0 Platelet count decreased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 1 / 32 (3.13%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 1 1 1 0 0 2 0 0 1 0 0 0 2 0 Protein total decreased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 Protein total increased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 Transaminases increased      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 3 / 22 (13.64%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 2 / 17 (11.76%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 2 / 16 (12.50%) 1 / 42 (2.38%) 1 / 32 (3.13%) 2 / 41 (4.88%) 7 / 80 (8.75%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 2 / 15 (13.33%) 7 / 26 (26.92%) 3 / 20 (15.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 3 0 1 0 3 0 0 3 0 0 2 2 1 2 9 0 1 0 0 1 0 0 4 8 4 0 Urine output decreased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Vitamin B12 decreased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 White blood cell count increased      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 Weight increased      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 1 0 0 0 0 0 Weight decreased      subjects affected / exposed 1 / 10 (10.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 1 / 18 (5.56%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 2 / 12 (16.67%) 0 / 14 (0.00%) 1 / 14 (7.14%) 2 / 15 (13.33%) 0 / 35 (0.00%) 1 / 16 (6.25%) 1 / 42 (2.38%) 2 / 32 (6.25%) 2 / 41 (4.88%) 7 / 80 (8.75%) 1 / 17 (5.88%) 3 / 79 (3.80%) 2 / 9 (22.22%) 0 / 6 (0.00%) 3 / 37 (8.11%) 0 / 14 (0.00%) 0 / 1 (0.00%) 2 / 15 (13.33%) 4 / 26 (15.38%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 1 1 0 0 1 1 0 1 0 2 0 1 2 0 1 2 2 2 7 1 3 2 0 3 0 0 2 4 1 0 Injury, poisoning and procedural complications Alcohol poisoning      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Anastomotic leak      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 Eye contusion      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Contusion      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 1 0 0 1 0 0 0 1 0 0 1 0 0 0 0 2 0 0 0 0 0 0 0 0 0 Arthropod sting      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 Face injury      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Infusion related reaction      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 3 / 18 (16.67%) 1 / 6 (16.67%) 0 / 18 (0.00%) 1 / 17 (5.88%) 1 / 12 (8.33%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 1 / 35 (2.86%) 2 / 16 (12.50%) 2 / 42 (4.76%) 2 / 32 (6.25%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 6 / 79 (7.59%) 1 / 9 (11.11%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 4 / 26 (15.38%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 3 1 0 1 2 0 1 0 1 2 2 3 0 1 0 9 1 2 0 0 0 3 4 1 0 Fall      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 1 / 6 (16.67%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 2 / 42 (4.76%) 0 / 32 (0.00%) 0 / 41 (0.00%) 3 / 80 (3.75%) 1 / 17 (5.88%) 3 / 79 (3.80%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 1 1 0 2 0 0 0 1 0 0 3 0 0 3 1 3 1 0 0 0 0 0 1 0 0 Post procedural haematuria      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Post procedural haemorrhage      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Postoperative wound complication      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Procedural pneumothorax      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Procedural pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 2 / 17 (11.76%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 3 / 79 (3.80%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 2 0 0 0 0 0 0 1 0 0 0 0 3 0 0 0 0 0 0 0 0 0 Stoma site erythema      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Radiation injury      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Upper limb fracture      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Vascular access site pain      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 Vascular access site bruising      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Wound complication      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 Wound secretion      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Wrist fracture      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 Congenital, familial and genetic disorders Porokeratosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Cardiac disorders Atrial flutter      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 2 / 15 (13.33%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 Palpitations      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 2 / 17 (11.76%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 2 2 0 0 0 0 0 1 1 0 0 Supraventricular tachycardia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 Sinus tachycardia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 2 / 41 (4.88%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 1 0 1 0 0 0 0 0 2 0 0 0 Tachycardia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 2 / 32 (6.25%) 0 / 41 (0.00%) 3 / 80 (3.75%) 0 / 17 (0.00%) 1 / 79 (1.27%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 2 0 3 0 1 1 0 0 0 0 0 1 1 0 Nervous system disorders Ageusia      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Dizziness      subjects affected / exposed 1 / 10 (10.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 5 / 18 (27.78%) 0 / 6 (0.00%) 0 / 18 (0.00%) 2 / 17 (11.76%) 2 / 12 (16.67%) 2 / 14 (14.29%) 3 / 14 (21.43%) 1 / 15 (6.67%) 1 / 35 (2.86%) 1 / 16 (6.25%) 5 / 42 (11.90%) 2 / 32 (6.25%) 3 / 41 (7.32%) 9 / 80 (11.25%) 2 / 17 (11.76%) 7 / 79 (8.86%) 1 / 9 (11.11%) 0 / 6 (0.00%) 5 / 37 (13.51%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 3 / 26 (11.54%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 1 0 0 0 5 0 0 2 2 2 3 1 1 1 5 2 3 13 2 9 1 0 6 1 0 0 4 0 0 Disturbance in attention      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 Central nervous system necrosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 Dizziness postural      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 Headache      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 1 / 1 (100.00%) 0 / 22 (0.00%) 5 / 18 (27.78%) 2 / 6 (33.33%) 2 / 18 (11.11%) 1 / 17 (5.88%) 1 / 12 (8.33%) 2 / 14 (14.29%) 1 / 14 (7.14%) 2 / 15 (13.33%) 5 / 35 (14.29%) 2 / 16 (12.50%) 6 / 42 (14.29%) 5 / 32 (15.63%) 1 / 41 (2.44%) 15 / 80 (18.75%) 1 / 17 (5.88%) 17 / 79 (21.52%) 1 / 9 (11.11%) 3 / 6 (50.00%) 5 / 37 (13.51%) 1 / 14 (7.14%) 0 / 1 (0.00%) 1 / 15 (6.67%) 9 / 26 (34.62%) 4 / 20 (20.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 1 0 5 4 3 2 3 2 1 2 5 2 7 7 1 15 1 26 1 4 7 1 0 3 10 4 0 Head discomfort      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Dysgeusia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 3 / 32 (9.38%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 5 / 79 (6.33%) 0 / 9 (0.00%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 3 0 1 0 5 0 0 2 0 0 0 0 0 0 Memory impairment      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 1 0 Lethargy      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 Hypoaesthesia      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 2 / 41 (4.88%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 Muscle contractions involuntary      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Neuralgia      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 1 / 42 (2.38%) 3 / 32 (9.38%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 1 4 0 0 0 2 0 0 0 0 0 0 0 0 0 Neuropathy peripheral      subjects affected / exposed 1 / 10 (10.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 2 / 18 (11.11%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 1 / 15 (6.67%) 2 / 35 (5.71%) 1 / 16 (6.25%) 1 / 42 (2.38%) 2 / 32 (6.25%) 1 / 41 (2.44%) 3 / 80 (3.75%) 1 / 17 (5.88%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 1 0 0 1 2 0 0 0 0 1 0 1 2 1 1 2 1 3 1 1 0 0 0 0 0 0 0 0 0 Paraesthesia      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 6 / 79 (7.59%) 1 / 9 (11.11%) 0 / 6 (0.00%) 3 / 37 (8.11%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 1 1 0 0 0 0 0 1 0 0 0 0 2 0 7 1 0 3 0 0 0 3 0 0 Parkinsonism      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Peripheral motor neuropathy      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 Peripheral sensory neuropathy      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 1 0 Presyncope      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 6 / 79 (7.59%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 7 0 0 0 0 0 0 1 0 0 Sciatica      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 2 0 0 0 1 0 0 Radiculopathy      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Psychomotor skills impaired      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Seizure      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 Sensory disturbance      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 3 / 26 (11.54%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 0 0 Somnolence      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 2 / 22 (9.09%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 2 1 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 Taste disorder      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 2 / 16 (12.50%) 1 / 42 (2.38%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 1 1 0 0 0 0 0 0 3 1 1 0 0 0 2 0 0 0 0 0 1 1 0 0 Tremor      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 3 / 79 (3.80%) 0 / 9 (0.00%) 0 / 6 (0.00%) 3 / 37 (8.11%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 2 0 3 0 0 4 0 0 0 1 0 0 Blood and lymphatic system disorders Anaemia      subjects affected / exposed 2 / 10 (20.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 4 / 22 (18.18%) 7 / 18 (38.89%) 2 / 6 (33.33%) 5 / 18 (27.78%) 4 / 17 (23.53%) 6 / 12 (50.00%) 3 / 14 (21.43%) 1 / 14 (7.14%) 2 / 15 (13.33%) 7 / 35 (20.00%) 3 / 16 (18.75%) 1 / 42 (2.38%) 13 / 32 (40.63%) 8 / 41 (19.51%) 16 / 80 (20.00%) 1 / 17 (5.88%) 9 / 79 (11.39%) 3 / 9 (33.33%) 0 / 6 (0.00%) 2 / 37 (5.41%) 3 / 14 (21.43%) 0 / 1 (0.00%) 2 / 15 (13.33%) 1 / 26 (3.85%) 2 / 20 (10.00%) 0 / 1 (0.00%)      occurrences all number 3 1 0 0 4 13 2 6 4 8 3 1 2 9 4 1 18 10 20 1 9 5 0 4 3 0 3 1 2 0 Febrile neutropenia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Lymph node haemorrhage      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Leukocytosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 3 / 80 (3.75%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 2 0 3 0 0 0 0 0 0 0 0 0 0 0 Lymphopenia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 1 / 41 (2.44%) 3 / 80 (3.75%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 4 0 0 1 0 1 0 0 0 0 0 0 Hyperleukocytosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 Thrombocytopenia      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 2 / 18 (11.11%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 3 / 35 (8.57%) 0 / 16 (0.00%) 2 / 42 (4.76%) 1 / 32 (3.13%) 1 / 41 (2.44%) 2 / 80 (2.50%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 2 / 20 (10.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 2 0 0 0 0 0 0 1 3 0 2 1 1 2 0 0 0 0 0 1 0 0 0 2 0 Neutropenia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 3 / 35 (8.57%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 3 0 0 0 0 2 0 0 0 0 0 1 0 0 0 1 0 Methaemoglobinaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Ear and labyrinth disorders Ear discomfort      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Hypoacusis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 2 0 2 0 0 0 0 0 0 0 0 0 Ear pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 3 / 79 (3.80%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 3 0 0 0 0 0 0 1 0 0 Ear disorder      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 Tinnitus      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 2 / 32 (6.25%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 2 0 0 0 0 0 0 1 0 0 Vertigo      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 1 / 35 (2.86%) 0 / 16 (0.00%) 1 / 42 (2.38%) 4 / 32 (12.50%) 0 / 41 (0.00%) 3 / 80 (3.75%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 1 0 0 0 1 2 0 1 4 0 3 0 2 0 0 1 0 0 0 0 0 0 Tympanic membrane perforation      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Eye disorders Blepharitis      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 Cataract      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 2 0 0 0 0 2 0 1 0 0 0 0 0 1 0 0 0 Diplopia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 1 / 1 (100.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 0 3 0 0 0 0 1 0 0 0 0 Dry eye      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 2 / 32 (6.25%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 5 / 79 (6.33%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 3 / 26 (11.54%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 2 0 0 1 5 0 0 0 0 0 0 3 0 0 Eye pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 Eyelid rash      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Periorbital pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Photophobia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 Uveitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 0 Swelling of eyelid      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Vitreous floaters      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 2 0 0 1 0 0 0 1 0 0 Visual impairment      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 1 1 0 0 0 1 0 0 0 0 0 0 0 Vision blurred      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 4 / 79 (5.06%) 1 / 9 (11.11%) 0 / 6 (0.00%) 1 / 37 (2.70%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 3 / 26 (11.54%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 4 1 0 1 1 0 0 3 0 0 Gastrointestinal disorders Abdominal discomfort      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 2 / 42 (4.76%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 1 0 0 0 0 2 0 0 0 1 0 0 0 2 0 0 0 0 1 0 Abdominal distension      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 2 / 18 (11.11%) 0 / 6 (0.00%) 2 / 18 (11.11%) 0 / 17 (0.00%) 1 / 12 (8.33%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 4 / 79 (5.06%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 1 / 15 (6.67%) 3 / 26 (11.54%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 2 0 2 0 1 1 0 0 0 1 0 1 0 0 1 4 0 0 0 1 0 1 3 0 0 Abdominal hernia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Abdominal pain      subjects affected / exposed 2 / 10 (20.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 5 / 22 (22.73%) 3 / 18 (16.67%) 2 / 6 (33.33%) 2 / 18 (11.11%) 2 / 17 (11.76%) 2 / 12 (16.67%) 0 / 14 (0.00%) 1 / 14 (7.14%) 1 / 15 (6.67%) 4 / 35 (11.43%) 4 / 16 (25.00%) 6 / 42 (14.29%) 2 / 32 (6.25%) 4 / 41 (9.76%) 9 / 80 (11.25%) 2 / 17 (11.76%) 12 / 79 (15.19%) 1 / 9 (11.11%) 1 / 6 (16.67%) 2 / 37 (5.41%) 2 / 14 (14.29%) 0 / 1 (0.00%) 1 / 15 (6.67%) 4 / 26 (15.38%) 2 / 20 (10.00%) 0 / 1 (0.00%)      occurrences all number 2 1 0 0 5 3 2 2 4 2 0 1 1 4 6 6 2 4 13 2 15 1 2 2 2 0 1 6 2 0 Abdominal pain lower      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 1 0 0 1 0 0 1 0 1 0 1 0 0 0 0 0 0 0 1 0 0 Abdominal pain upper      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 3 / 18 (16.67%) 1 / 6 (16.67%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 3 / 14 (21.43%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 2 / 32 (6.25%) 1 / 41 (2.44%) 4 / 80 (5.00%) 2 / 17 (11.76%) 9 / 79 (11.39%) 0 / 9 (0.00%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 1 3 1 1 0 0 0 3 0 1 0 0 2 1 6 2 11 0 0 2 0 0 0 2 0 0 Anal fissure      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 1 / 1 (100.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 Colitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 2 / 16 (12.50%) 1 / 42 (2.38%) 1 / 32 (3.13%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 1 1 0 2 0 2 0 0 2 0 0 0 0 0 0 Breath odour      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 Ascites      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 3 / 22 (13.64%) 0 / 18 (0.00%) 1 / 6 (16.67%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 3 0 1 3 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 2 1 0 Constipation      subjects affected / exposed 3 / 10 (30.00%) 2 / 7 (28.57%) 0 / 1 (0.00%) 0 / 1 (0.00%) 5 / 22 (22.73%) 7 / 18 (38.89%) 4 / 6 (66.67%) 6 / 18 (33.33%) 2 / 17 (11.76%) 3 / 12 (25.00%) 0 / 14 (0.00%) 4 / 14 (28.57%) 4 / 15 (26.67%) 7 / 35 (20.00%) 4 / 16 (25.00%) 9 / 42 (21.43%) 8 / 32 (25.00%) 8 / 41 (19.51%) 10 / 80 (12.50%) 5 / 17 (29.41%) 12 / 79 (15.19%) 4 / 9 (44.44%) 1 / 6 (16.67%) 7 / 37 (18.92%) 4 / 14 (28.57%) 0 / 1 (0.00%) 2 / 15 (13.33%) 9 / 26 (34.62%) 3 / 20 (15.00%) 0 / 1 (0.00%)      occurrences all number 4 4 0 0 5 7 4 6 2 3 0 4 4 8 5 11 9 8 10 7 13 4 1 7 5 0 2 10 3 0 Duodenal ulcer      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Dry mouth      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 1 / 18 (5.56%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 1 / 14 (7.14%) 0 / 14 (0.00%) 1 / 15 (6.67%) 1 / 35 (2.86%) 0 / 16 (0.00%) 1 / 42 (2.38%) 3 / 32 (9.38%) 0 / 41 (0.00%) 1 / 80 (1.25%) 1 / 17 (5.88%) 15 / 79 (18.99%) 1 / 9 (11.11%) 1 / 6 (16.67%) 1 / 37 (2.70%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 4 / 26 (15.38%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 1 1 0 0 1 1 0 1 1 0 2 3 0 1 1 15 1 1 1 1 0 0 4 0 0 Diarrhoea      subjects affected / exposed 1 / 10 (10.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 4 / 22 (18.18%) 3 / 18 (16.67%) 2 / 6 (33.33%) 5 / 18 (27.78%) 5 / 17 (29.41%) 2 / 12 (16.67%) 2 / 14 (14.29%) 1 / 14 (7.14%) 2 / 15 (13.33%) 3 / 35 (8.57%) 3 / 16 (18.75%) 8 / 42 (19.05%) 8 / 32 (25.00%) 3 / 41 (7.32%) 19 / 80 (23.75%) 2 / 17 (11.76%) 16 / 79 (20.25%) 1 / 9 (11.11%) 3 / 6 (50.00%) 5 / 37 (13.51%) 5 / 14 (35.71%) 0 / 1 (0.00%) 5 / 15 (33.33%) 8 / 26 (30.77%) 2 / 20 (10.00%) 0 / 1 (0.00%)      occurrences all number 1 1 0 0 4 4 2 5 5 5 2 1 3 4 4 10 9 4 25 2 30 1 5 5 6 0 5 12 3 0 Enteritis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 1 0 0 0 0 0 0 Dysphagia      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 3 / 14 (21.43%) 2 / 15 (13.33%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 2 / 41 (4.88%) 1 / 80 (1.25%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 1 / 1 (100.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 0 1 1 0 0 0 3 2 0 0 0 1 2 1 0 2 0 0 2 0 1 0 0 1 0 Dyspepsia      subjects affected / exposed 3 / 10 (30.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 2 / 17 (11.76%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 2 / 42 (4.76%) 1 / 32 (3.13%) 1 / 41 (2.44%) 3 / 80 (3.75%) 1 / 17 (5.88%) 4 / 79 (5.06%) 0 / 9 (0.00%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 3 / 20 (15.00%) 0 / 1 (0.00%)      occurrences all number 3 0 0 0 0 0 0 1 2 1 0 0 0 0 0 2 1 1 3 1 7 0 0 2 0 0 0 0 3 0 Flatulence      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 1 / 32 (3.13%) 2 / 41 (4.88%) 2 / 80 (2.50%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 1 2 2 0 1 0 0 0 0 0 0 0 0 0 Gastritis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 4 / 79 (5.06%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 4 0 0 0 0 0 0 1 1 0 Gastrointestinal pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 2 / 32 (6.25%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 Gastrooesophageal reflux disease      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 2 / 18 (11.11%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 2 / 35 (5.71%) 0 / 16 (0.00%) 2 / 42 (4.76%) 4 / 32 (12.50%) 2 / 41 (4.88%) 5 / 80 (6.25%) 1 / 17 (5.88%) 6 / 79 (7.59%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 2 0 0 0 0 0 0 0 2 0 2 4 2 5 1 6 0 0 0 0 0 0 2 1 0 Haemorrhoids      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 1 / 32 (3.13%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 1 0 0 2 0 0 0 0 0 0 0 1 0 Immune-mediated enterocolitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 Hypoaesthesia oral      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 1 0 0 0 0 0 0 0 Intra-abdominal fluid collection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 Mouth haemorrhage      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Lip oedema      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Large intestinal obstruction      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Mouth ulceration      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 2 1 0 0 0 0 0 0 0 0 Nausea      subjects affected / exposed 3 / 10 (30.00%) 4 / 7 (57.14%) 0 / 1 (0.00%) 0 / 1 (0.00%) 9 / 22 (40.91%) 8 / 18 (44.44%) 3 / 6 (50.00%) 9 / 18 (50.00%) 3 / 17 (17.65%) 6 / 12 (50.00%) 4 / 14 (28.57%) 4 / 14 (28.57%) 3 / 15 (20.00%) 10 / 35 (28.57%) 7 / 16 (43.75%) 18 / 42 (42.86%) 16 / 32 (50.00%) 7 / 41 (17.07%) 24 / 80 (30.00%) 5 / 17 (29.41%) 32 / 79 (40.51%) 3 / 9 (33.33%) 1 / 6 (16.67%) 10 / 37 (27.03%) 6 / 14 (42.86%) 1 / 1 (100.00%) 5 / 15 (33.33%) 11 / 26 (42.31%) 9 / 20 (45.00%) 0 / 1 (0.00%)      occurrences all number 4 5 0 0 10 10 4 11 5 10 5 4 7 10 8 19 19 8 26 5 43 3 1 10 7 1 5 13 9 0 Odynophagia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 2 / 42 (4.76%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 2 0 0 0 0 0 0 0 1 0 0 0 0 0 0 Oesophagitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 Oral pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 3 / 26 (11.54%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 0 0 Pancreatitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 Rectal haemorrhage      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 2 / 42 (4.76%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 2 0 0 0 0 1 1 0 0 0 0 0 0 0 0 Salivary hypersecretion      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Small intestinal obstruction      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Stomatitis      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 2 / 18 (11.11%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 2 / 35 (5.71%) 2 / 16 (12.50%) 1 / 42 (2.38%) 2 / 32 (6.25%) 1 / 41 (2.44%) 3 / 80 (3.75%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 2 / 37 (5.41%) 2 / 14 (14.29%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 1 0 0 2 0 1 0 0 1 2 2 1 3 2 3 0 0 0 0 2 2 0 0 3 0 0 Swollen tongue      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Tongue oedema      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 2 / 15 (13.33%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Vomiting      subjects affected / exposed 6 / 10 (60.00%) 4 / 7 (57.14%) 0 / 1 (0.00%) 1 / 1 (100.00%) 6 / 22 (27.27%) 8 / 18 (44.44%) 4 / 6 (66.67%) 7 / 18 (38.89%) 3 / 17 (17.65%) 6 / 12 (50.00%) 2 / 14 (14.29%) 4 / 14 (28.57%) 3 / 15 (20.00%) 2 / 35 (5.71%) 2 / 16 (12.50%) 11 / 42 (26.19%) 9 / 32 (28.13%) 4 / 41 (9.76%) 19 / 80 (23.75%) 3 / 17 (17.65%) 16 / 79 (20.25%) 2 / 9 (22.22%) 0 / 6 (0.00%) 2 / 37 (5.41%) 1 / 14 (7.14%) 0 / 1 (0.00%) 4 / 15 (26.67%) 3 / 26 (11.54%) 4 / 20 (20.00%) 0 / 1 (0.00%)      occurrences all number 8 8 0 1 7 8 5 7 3 8 2 5 6 2 3 15 9 7 23 3 23 2 0 2 1 0 7 6 4 0 Hepatobiliary disorders Autoimmune hepatitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 2 / 18 (11.11%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 2 1 0 0 0 1 0 0 0 0 0 0 0 2 0 1 0 0 0 0 0 0 1 1 0 Hepatic cytolysis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 2 / 22 (9.09%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 5 / 35 (14.29%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 2 0 0 1 0 0 0 0 0 5 0 0 0 0 3 0 2 0 0 0 0 0 0 0 0 0 Hepatotoxicity      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 1 / 1 (100.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 1 0 0 0 0 1 0 0 0 0 1 0 0 0 0 Hyperbilirubinaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 2 / 22 (9.09%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 2 1 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Immune-mediated hepatitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 2 / 16 (12.50%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 2 / 20 (10.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 3 0 1 0 0 0 0 0 0 1 2 0 Skin and subcutaneous tissue disorders Actinic keratosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 2 0 0 1 0 0 0 1 0 0 Alopecia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 1 0 0 0 0 1 0 0 0 Dermatitis acneiform      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 2 / 14 (14.29%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 4 / 16 (25.00%) 1 / 42 (2.38%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 0 0 0 0 0 3 0 0 0 4 1 1 0 0 0 1 0 0 0 0 0 0 1 0 0 Dermatitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 0 0 1 0 0 0 1 0 1 0 0 0 Dermatitis contact      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 1 1 0 Dry skin      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 2 / 17 (11.76%) 0 / 12 (0.00%) 2 / 14 (14.29%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 2 / 32 (6.25%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 4 / 79 (5.06%) 0 / 9 (0.00%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 1 0 0 2 0 2 0 1 0 0 1 2 0 1 0 4 0 0 2 0 0 0 3 1 0 Hair colour changes      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 Erythema      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 2 / 42 (4.76%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 2 1 0 0 0 0 1 0 1 0 0 1 0 0 0 Hyperhidrosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 2 / 22 (9.09%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 2 / 42 (4.76%) 1 / 32 (3.13%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 2 0 0 0 2 1 0 0 0 0 0 2 1 1 0 0 1 0 0 1 0 0 0 0 0 0 Intertrigo      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 1 / 9 (11.11%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 1 0 1 0 0 0 0 0 0 Macule      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 2 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Nail hypertrophy      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Night sweats      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 2 / 35 (5.71%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 3 / 17 (17.65%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 1 0 0 0 1 0 0 0 2 0 0 0 1 0 3 1 0 0 0 0 0 1 2 0 0 Onychoclasis      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Onycholysis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Pain of skin      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 2 / 32 (6.25%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 Palmar-plantar erythrodysaesthesia syndrome      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 1 0 0 3 0 0 0 0 0 0 0 0 0 0 0 Psoriasis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 Pruritus      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 3 / 17 (17.65%) 1 / 12 (8.33%) 3 / 14 (21.43%) 0 / 14 (0.00%) 1 / 15 (6.67%) 2 / 35 (5.71%) 2 / 16 (12.50%) 5 / 42 (11.90%) 8 / 32 (25.00%) 4 / 41 (9.76%) 10 / 80 (12.50%) 3 / 17 (17.65%) 15 / 79 (18.99%) 1 / 9 (11.11%) 0 / 6 (0.00%) 9 / 37 (24.32%) 1 / 14 (7.14%) 0 / 1 (0.00%) 1 / 15 (6.67%) 3 / 26 (11.54%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 1 0 0 1 3 1 4 0 1 2 4 8 13 4 12 3 19 1 0 11 1 0 2 6 1 0 Pemphigoid      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Purpura      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Rash      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 2 / 22 (9.09%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 3 / 12 (25.00%) 3 / 14 (21.43%) 3 / 14 (21.43%) 1 / 15 (6.67%) 3 / 35 (8.57%) 2 / 16 (12.50%) 6 / 42 (14.29%) 8 / 32 (25.00%) 2 / 41 (4.88%) 3 / 80 (3.75%) 3 / 17 (17.65%) 18 / 79 (22.78%) 1 / 9 (11.11%) 2 / 6 (33.33%) 3 / 37 (8.11%) 2 / 14 (14.29%) 0 / 1 (0.00%) 1 / 15 (6.67%) 3 / 26 (11.54%) 4 / 20 (20.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 2 1 0 0 0 3 5 3 1 3 3 6 10 2 3 4 26 1 4 4 2 0 3 3 5 0 Rash erythematous      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 Rash macular      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 Rash maculo-papular      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 2 / 18 (11.11%) 2 / 17 (11.76%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 1 / 15 (6.67%) 1 / 35 (2.86%) 1 / 16 (6.25%) 4 / 42 (9.52%) 1 / 32 (3.13%) 2 / 41 (4.88%) 1 / 80 (1.25%) 0 / 17 (0.00%) 12 / 79 (15.19%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 5 / 26 (19.23%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 1 0 2 2 0 0 1 1 1 1 4 1 2 1 0 13 0 0 0 2 0 0 7 0 0 Rash pruritic      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 1 / 6 (16.67%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 2 0 1 1 0 0 1 1 0 0 Rosacea      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 Scar pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Skin discolouration      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 Skin erosion      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Skin haemorrhage      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 Skin hypopigmentation      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 5 / 79 (6.33%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 0 0 0 0 0 0 1 0 0 Skin irritation      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 Skin lesion      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 3 / 79 (3.80%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 3 0 0 0 0 0 1 2 0 0 Skin ulcer      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 Urticaria      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 Vitiligo      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 9 / 79 (11.39%) 1 / 9 (11.11%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 9 1 0 1 0 0 0 1 0 0 Xeroderma      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 2 / 35 (5.71%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Renal and urinary disorders Acute kidney injury      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 1 0 0 0 1 0 0 0 0 0 0 0 1 0 0 0 0 0 0 Chromaturia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Cystitis noninfective      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Dysuria      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 1 / 18 (5.56%) 0 / 6 (0.00%) 2 / 18 (11.11%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 3 / 35 (8.57%) 2 / 16 (12.50%) 1 / 42 (2.38%) 1 / 32 (3.13%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 3 / 79 (3.80%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 2 0 2 0 1 0 0 0 3 3 1 1 0 1 0 3 0 0 0 0 0 0 0 0 0 Haematuria      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 1 / 14 (7.14%) 1 / 15 (6.67%) 0 / 35 (0.00%) 3 / 16 (18.75%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 1 0 0 1 1 1 0 4 0 1 0 1 0 1 0 0 0 0 0 0 0 0 0 Hydronephrosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Nephrolithiasis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 Nocturia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 0 Pollakiuria      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 1 1 0 0 0 1 0 0 0 0 0 0 0 0 0 Urinary retention      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 1 / 80 (1.25%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 1 1 1 0 0 0 0 0 0 0 0 1 0 Urinary incontinence      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 3 / 79 (3.80%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 1 / 1 (100.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 1 3 0 0 0 0 1 0 0 0 0 Urinary tract obstruction      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 Urinary tract disorder      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 Urine odour abnormal      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Endocrine disorders Adrenal insufficiency      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 3 / 26 (11.54%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 3 0 0 Hypothyroidism      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 3 / 17 (17.65%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 2 / 16 (12.50%) 5 / 42 (11.90%) 3 / 32 (9.38%) 1 / 41 (2.44%) 6 / 80 (7.50%) 0 / 17 (0.00%) 8 / 79 (10.13%) 1 / 9 (11.11%) 1 / 6 (16.67%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 1 / 15 (6.67%) 3 / 26 (11.54%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 0 0 0 3 0 0 0 0 0 2 5 3 1 6 0 8 1 1 0 1 0 1 4 1 0 Hypophysitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 2 0 0 Hyperthyroidism      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 4 / 42 (9.52%) 1 / 32 (3.13%) 0 / 41 (0.00%) 5 / 80 (6.25%) 0 / 17 (0.00%) 5 / 79 (6.33%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 4 / 26 (15.38%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 1 0 4 1 0 6 0 6 1 0 0 0 0 0 4 0 0 Inappropriate antidiuretic hormone secretion      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Thyroiditis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 1 / 1 (100.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 1 0 0 Musculoskeletal and connective tissue disorders Arthralgia      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 4 / 18 (22.22%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 3 / 12 (25.00%) 2 / 14 (14.29%) 2 / 14 (14.29%) 1 / 15 (6.67%) 3 / 35 (8.57%) 4 / 16 (25.00%) 11 / 42 (26.19%) 7 / 32 (21.88%) 4 / 41 (9.76%) 17 / 80 (21.25%) 1 / 17 (5.88%) 18 / 79 (22.78%) 1 / 9 (11.11%) 0 / 6 (0.00%) 3 / 37 (8.11%) 2 / 14 (14.29%) 0 / 1 (0.00%) 1 / 15 (6.67%) 5 / 26 (19.23%) 3 / 20 (15.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 1 4 0 0 0 3 2 2 1 3 6 16 7 4 19 1 20 1 0 3 2 0 1 6 4 0 Arthritis      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 Bone pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 4 / 80 (5.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 1 1 0 0 0 1 5 0 0 0 0 1 0 0 0 0 0 0 Bone lesion      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Back pain      subjects affected / exposed 3 / 10 (30.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 3 / 22 (13.64%) 5 / 18 (27.78%) 1 / 6 (16.67%) 3 / 18 (16.67%) 1 / 17 (5.88%) 5 / 12 (41.67%) 2 / 14 (14.29%) 0 / 14 (0.00%) 2 / 15 (13.33%) 2 / 35 (5.71%) 3 / 16 (18.75%) 5 / 42 (11.90%) 5 / 32 (15.63%) 2 / 41 (4.88%) 11 / 80 (13.75%) 1 / 17 (5.88%) 13 / 79 (16.46%) 0 / 9 (0.00%) 1 / 6 (16.67%) 4 / 37 (10.81%) 1 / 14 (7.14%) 0 / 1 (0.00%) 2 / 15 (13.33%) 5 / 26 (19.23%) 3 / 20 (15.00%) 0 / 1 (0.00%)      occurrences all number 3 0 0 0 4 5 1 3 1 7 2 0 2 2 3 5 7 2 14 2 14 0 1 4 1 0 2 6 3 0 Costochondritis      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Flank pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 2 / 16 (12.50%) 2 / 42 (4.76%) 0 / 32 (0.00%) 2 / 41 (4.88%) 2 / 80 (2.50%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 1 0 1 0 3 2 0 2 2 0 1 0 1 0 1 0 0 2 0 0 Fistula      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Groin pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 2 / 12 (16.67%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 4 / 79 (5.06%) 0 / 9 (0.00%) 1 / 6 (16.67%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 2 0 0 0 1 0 0 0 0 0 1 5 0 1 2 0 0 1 1 0 0 Joint stiffness      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 0 0 0 0 0 0 Limb mass      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 Joint swelling      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 1 0 0 0 0 0 0 1 0 0 Muscle spasms      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 1 / 16 (6.25%) 0 / 42 (0.00%) 2 / 32 (6.25%) 1 / 41 (2.44%) 5 / 80 (6.25%) 1 / 17 (5.88%) 5 / 79 (6.33%) 1 / 9 (11.11%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 3 0 0 0 1 1 0 2 1 5 1 5 1 0 2 0 0 1 2 0 0 Muscular weakness      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 2 / 18 (11.11%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 1 / 41 (2.44%) 4 / 80 (5.00%) 3 / 17 (17.65%) 2 / 79 (2.53%) 0 / 9 (0.00%) 1 / 6 (16.67%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 2 0 1 0 1 0 0 0 0 0 1 0 1 4 3 2 0 1 2 0 0 0 1 1 0 Musculoskeletal chest pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 3 / 18 (16.67%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 2 / 14 (14.29%) 2 / 15 (13.33%) 0 / 35 (0.00%) 1 / 16 (6.25%) 3 / 42 (7.14%) 3 / 32 (9.38%) 0 / 41 (0.00%) 5 / 80 (6.25%) 1 / 17 (5.88%) 3 / 79 (3.80%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 1 / 14 (7.14%) 0 / 1 (0.00%) 1 / 15 (6.67%) 1 / 26 (3.85%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 4 1 0 0 0 1 4 2 0 1 3 4 0 5 1 6 0 0 1 1 0 1 1 1 0 Musculoskeletal pain      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 4 / 41 (9.76%) 3 / 80 (3.75%) 1 / 17 (5.88%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 1 0 0 1 0 0 0 0 2 0 4 3 1 1 0 0 1 0 0 0 0 0 0 Musculoskeletal stiffness      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 2 0 0 Myalgia      subjects affected / exposed 0 / 10 (0.00%) 2 / 7 (28.57%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 1 / 17 (5.88%) 3 / 12 (25.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 1 / 15 (6.67%) 1 / 35 (2.86%) 1 / 16 (6.25%) 3 / 42 (7.14%) 2 / 32 (6.25%) 0 / 41 (0.00%) 4 / 80 (5.00%) 3 / 17 (17.65%) 2 / 79 (2.53%) 1 / 9 (11.11%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 2 0 0 0 0 1 0 1 3 0 1 2 1 1 3 2 0 4 3 2 1 0 1 0 0 1 3 0 0 Neck pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 1 / 14 (7.14%) 1 / 15 (6.67%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 2 / 41 (4.88%) 2 / 80 (2.50%) 0 / 17 (0.00%) 3 / 79 (3.80%) 1 / 9 (11.11%) 0 / 6 (0.00%) 4 / 37 (10.81%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 1 1 1 0 0 0 2 2 0 3 1 0 4 0 0 0 0 0 0 Osteoporosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 2 / 16 (12.50%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Pain in jaw      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 2 0 0 0 0 0 0 0 0 0 Pain in extremity      subjects affected / exposed 3 / 10 (30.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 1 / 18 (5.56%) 0 / 6 (0.00%) 1 / 18 (5.56%) 2 / 17 (11.76%) 2 / 12 (16.67%) 1 / 14 (7.14%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 2 / 16 (12.50%) 4 / 42 (9.52%) 2 / 32 (6.25%) 3 / 41 (7.32%) 3 / 80 (3.75%) 0 / 17 (0.00%) 8 / 79 (10.13%) 2 / 9 (22.22%) 0 / 6 (0.00%) 1 / 37 (2.70%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 2 / 26 (7.69%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 3 0 0 0 1 1 0 1 2 4 1 0 1 0 2 4 2 3 3 0 10 2 0 1 1 0 0 2 1 0 Pathological fracture      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 Rheumatic disorder      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 2 0 0 0 0 0 0 Synovial cyst      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 Spinal pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Sacral pain      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Infections and infestations Abdominal infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Bronchitis viral      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 Bronchitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 2 / 35 (5.71%) 1 / 16 (6.25%) 0 / 42 (0.00%) 3 / 32 (9.38%) 1 / 41 (2.44%) 5 / 80 (6.25%) 0 / 17 (0.00%) 2 / 79 (2.53%) 1 / 9 (11.11%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 2 1 0 3 1 6 0 2 1 0 2 0 0 0 0 0 0 Acarodermatitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 0 1 0 0 0 Cellulitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 5 1 0 0 0 0 0 0 0 0 Catheter site infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Catheter site cellulitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 Clostridium difficile infection      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Conjunctivitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 Conjunctivitis viral      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 Cystitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 0 1 0 0 0 0 0 0 0 0 0 0 0 Device related infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Ear infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 2 / 18 (11.11%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 2 0 0 0 0 0 0 0 1 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 Escherichia urinary tract infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 2 / 16 (12.50%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Eye infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Fungal infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 Gastric infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 Furuncle      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Fungal skin infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 2 / 32 (6.25%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 Genital herpes      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Gastroenteritis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 1 0 1 0 1 0 0 0 0 0 0 0 0 0 Helicobacter infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Herpes zoster      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 1 0 0 1 0 0 1 0 0 0 Herpes simplex      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Hordeolum      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 Infected dermal cyst      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 Lip infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 2 / 12 (16.67%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 2 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Influenza      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 1 / 16 (6.25%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 1 0 0 0 0 0 0 2 0 0 1 0 0 0 Infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 2 / 32 (6.25%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 2 0 0 0 0 0 0 1 0 0 0 0 0 0 Localised infection      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Lower respiratory tract infection      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 1 0 0 0 0 0 0 0 0 1 0 0 0 Mastoiditis      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Nasopharyngitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 2 / 35 (5.71%) 1 / 16 (6.25%) 0 / 42 (0.00%) 1 / 32 (3.13%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 5 / 79 (6.33%) 0 / 9 (0.00%) 2 / 6 (33.33%) 2 / 37 (5.41%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 0 0 0 0 0 1 0 0 3 1 0 1 1 0 0 6 0 2 2 0 0 0 1 0 0 Oral candidiasis      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 2 / 16 (12.50%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 1 / 14 (7.14%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 0 0 0 0 0 0 0 1 0 2 0 0 1 0 0 2 0 0 1 1 0 1 0 0 0 Onychomycosis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Oral herpes      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 2 / 32 (6.25%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1 2 0 1 0 2 0 0 1 1 0 0 0 0 0 Otitis externa      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Penile infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 1 / 16 (6.25%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Otitis media      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 Pharyngitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 Pneumonia      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 2 / 18 (11.11%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 2 / 12 (16.67%) 1 / 14 (7.14%) 2 / 14 (14.29%) 1 / 15 (6.67%) 2 / 35 (5.71%) 0 / 16 (0.00%) 1 / 42 (2.38%) 1 / 32 (3.13%) 2 / 41 (4.88%) 8 / 80 (10.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 2 0 1 0 2 1 2 1 2 0 1 1 2 8 0 1 0 0 1 1 0 0 0 1 0 Pneumonia staphylococcal      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Pyelonephritis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 Respiratory tract infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 1 0 0 0 0 0 0 0 0 0 1 0 1 0 0 2 0 0 0 0 0 0 0 0 0 Rhinitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 2 / 32 (6.25%) 1 / 41 (2.44%) 1 / 80 (1.25%) 0 / 17 (0.00%) 1 / 79 (1.27%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 2 1 1 0 1 1 0 0 0 0 0 0 0 0 Sepsis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 1 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Sinusitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 2 / 42 (4.76%) 1 / 32 (3.13%) 0 / 41 (0.00%) 2 / 80 (2.50%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 2 0 0 0 0 1 0 2 1 0 2 0 0 0 0 0 0 0 0 0 0 0 Skin infection      subjects affected / exposed 0 / 10 (0.00%) 1 / 7 (14.29%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 1 / 15 (6.67%) 2 / 35 (5.71%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 1 / 17 (5.88%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 1 0 0 0 0 1 0 1 0 1 0 1 2 0 0 0 0 2 1 1 0 0 1 0 0 0 0 0 0 Upper respiratory tract infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 5 / 18 (27.78%) 0 / 6 (0.00%) 2 / 18 (11.11%) 3 / 17 (17.65%) 0 / 12 (0.00%) 2 / 14 (14.29%) 1 / 14 (7.14%) 0 / 15 (0.00%) 1 / 35 (2.86%) 2 / 16 (12.50%) 5 / 42 (11.90%) 0 / 32 (0.00%) 2 / 41 (4.88%) 7 / 80 (8.75%) 1 / 17 (5.88%) 8 / 79 (10.13%) 0 / 9 (0.00%) 1 / 6 (16.67%) 0 / 37 (0.00%) 1 / 14 (7.14%) 0 / 1 (0.00%) 1 / 15 (6.67%) 5 / 26 (19.23%) 2 / 20 (10.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 5 0 2 3 0 3 1 0 1 4 6 0 2 7 1 8 0 1 0 1 0 1 6 2 0 Tooth infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 1 / 80 (1.25%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 3 0 0 0 1 0 2 0 2 0 0 0 0 0 1 0 0 0 Staphylococcal infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 1 / 1 (100.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 Urinary tract infection      subjects affected / exposed 1 / 10 (10.00%) 3 / 7 (42.86%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 3 / 18 (16.67%) 0 / 6 (0.00%) 1 / 18 (5.56%) 6 / 17 (35.29%) 1 / 12 (8.33%) 2 / 14 (14.29%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 2 / 16 (12.50%) 2 / 42 (4.76%) 7 / 32 (21.88%) 3 / 41 (7.32%) 7 / 80 (8.75%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 1 / 6 (16.67%) 1 / 37 (2.70%) 1 / 14 (7.14%) 0 / 1 (0.00%) 2 / 15 (13.33%) 1 / 26 (3.85%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 1 4 0 0 1 5 0 1 12 1 2 0 1 0 3 2 10 3 8 0 3 0 1 4 2 0 2 3 1 0 Urinary tract candidiasis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 Vascular device infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 1 / 1 (100.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 Viral upper respiratory tract infection      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 1 / 18 (5.56%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 Viral pharyngitis      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 Metabolism and nutrition disorders Decreased appetite      subjects affected / exposed 5 / 10 (50.00%) 3 / 7 (42.86%) 0 / 1 (0.00%) 0 / 1 (0.00%) 8 / 22 (36.36%) 7 / 18 (38.89%) 2 / 6 (33.33%) 10 / 18 (55.56%) 2 / 17 (11.76%) 6 / 12 (50.00%) 4 / 14 (28.57%) 1 / 14 (7.14%) 5 / 15 (33.33%) 4 / 35 (11.43%) 7 / 16 (43.75%) 10 / 42 (23.81%) 7 / 32 (21.88%) 12 / 41 (29.27%) 17 / 80 (21.25%) 3 / 17 (17.65%) 13 / 79 (16.46%) 3 / 9 (33.33%) 1 / 6 (16.67%) 1 / 37 (2.70%) 3 / 14 (21.43%) 0 / 1 (0.00%) 4 / 15 (26.67%) 4 / 26 (15.38%) 5 / 20 (25.00%) 0 / 1 (0.00%)      occurrences all number 5 3 0 0 9 8 2 10 2 7 4 1 5 4 7 10 7 12 18 3 13 3 1 1 3 0 4 4 5 0 Folate deficiency      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 Failure to thrive      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Dehydration      subjects affected / exposed 0 / 10 (0.00%) 2 / 7 (28.57%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 2 / 41 (4.88%) 1 / 80 (1.25%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 2 0 0 0 0 0 0 0 1 0 0 0 0 0 0 1 2 1 0 0 0 0 0 0 0 0 0 0 0 Hypercalcaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 2 / 18 (11.11%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 2 / 15 (13.33%) 1 / 35 (2.86%) 1 / 16 (6.25%) 1 / 42 (2.38%) 0 / 32 (0.00%) 1 / 41 (2.44%) 2 / 80 (2.50%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 2 0 1 0 0 0 1 2 1 1 1 0 1 2 0 0 0 0 1 2 0 0 1 0 0 Hyperglycaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 2 / 22 (9.09%) 0 / 18 (0.00%) 1 / 6 (16.67%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 2 / 15 (13.33%) 0 / 35 (0.00%) 1 / 16 (6.25%) 1 / 42 (2.38%) 0 / 32 (0.00%) 1 / 41 (2.44%) 8 / 80 (10.00%) 1 / 17 (5.88%) 2 / 79 (2.53%) 1 / 9 (11.11%) 1 / 6 (16.67%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 2 / 15 (13.33%) 2 / 26 (7.69%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 2 0 1 0 0 0 1 0 2 0 2 1 0 2 11 1 3 1 1 3 0 0 2 2 0 0 Hyperkalaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 2 / 15 (13.33%) 0 / 35 (0.00%) 1 / 16 (6.25%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 2 / 80 (2.50%) 1 / 17 (5.88%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 3 0 1 1 0 0 2 1 1 0 0 1 0 0 0 1 0 0 Hypermagnesaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 1 0 0 1 0 0 1 0 0 0 Hypernatraemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Hyperuricaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 1 / 14 (7.14%) 0 / 14 (0.00%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 1 / 41 (2.44%) 4 / 80 (5.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 1 0 0 1 0 1 0 1 4 0 0 0 0 0 0 0 0 0 0 0 Hypoalbuminaemia      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 2 / 12 (16.67%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 1 / 35 (2.86%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 4 / 80 (5.00%) 0 / 17 (0.00%) 1 / 79 (1.27%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 2 0 0 0 2 0 0 0 0 2 0 1 0 1 0 0 0 0 4 0 1 1 0 0 0 0 0 0 1 0 Hypocalcaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 1 / 17 (5.88%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 1 / 41 (2.44%) 1 / 80 (1.25%) 1 / 17 (5.88%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 0 / 14 (0.00%) 1 / 1 (100.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 1 1 1 0 0 0 1 0 1 1 0 1 0 Hypomagnesaemia      subjects affected / exposed 2 / 10 (20.00%) 2 / 7 (28.57%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 2 / 18 (11.11%) 0 / 6 (0.00%) 3 / 18 (16.67%) 1 / 17 (5.88%) 1 / 12 (8.33%) 1 / 14 (7.14%) 0 / 14 (0.00%) 2 / 15 (13.33%) 2 / 35 (5.71%) 0 / 16 (0.00%) 0 / 42 (0.00%) 4 / 32 (12.50%) 2 / 41 (4.88%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 0 / 37 (0.00%) 2 / 14 (14.29%) 0 / 1 (0.00%) 1 / 15 (6.67%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 2 2 0 0 0 2 0 3 2 1 1 0 2 2 0 0 4 2 0 0 0 1 0 0 3 0 2 0 1 0 Hypoglycaemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 1 / 15 (6.67%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 1 0 0 Hypokalaemia      subjects affected / exposed 1 / 10 (10.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 4 / 18 (22.22%) 1 / 6 (16.67%) 1 / 18 (5.56%) 2 / 17 (11.76%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 2 / 15 (13.33%) 2 / 35 (5.71%) 0 / 16 (0.00%) 0 / 42 (0.00%) 3 / 32 (9.38%) 4 / 41 (9.76%) 3 / 80 (3.75%) 0 / 17 (0.00%) 2 / 79 (2.53%) 0 / 9 (0.00%) 0 / 6 (0.00%) 3 / 37 (8.11%) 1 / 14 (7.14%) 1 / 1 (100.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 1 / 20 (5.00%) 0 / 1 (0.00%)      occurrences all number 1 0 0 0 0 4 1 1 3 1 0 0 2 2 0 0 3 4 3 0 2 0 0 3 1 1 0 0 1 0 Hyponatraemia      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 2 / 18 (11.11%) 0 / 6 (0.00%) 1 / 18 (5.56%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 2 / 16 (12.50%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 5 / 80 (6.25%) 1 / 17 (5.88%) 0 / 79 (0.00%) 1 / 9 (11.11%) 0 / 6 (0.00%) 2 / 37 (5.41%) 2 / 14 (14.29%) 0 / 1 (0.00%) 3 / 15 (20.00%) 3 / 26 (11.54%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 1 2 0 1 0 1 0 1 0 0 2 0 1 0 5 1 0 1 0 2 2 0 4 3 0 0 Hypophosphataemia      subjects affected / exposed 3 / 10 (30.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 1 / 22 (4.55%) 2 / 18 (11.11%) 1 / 6 (16.67%) 0 / 18 (0.00%) 1 / 17 (5.88%) 1 / 12 (8.33%) 2 / 14 (14.29%) 1 / 14 (7.14%) 0 / 15 (0.00%) 1 / 35 (2.86%) 2 / 16 (12.50%) 2 / 42 (4.76%) 2 / 32 (6.25%) 5 / 41 (12.20%) 2 / 80 (2.50%) 1 / 17 (5.88%) 7 / 79 (8.86%) 0 / 9 (0.00%) 0 / 6 (0.00%) 1 / 37 (2.70%) 1 / 14 (7.14%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 5 0 0 0 2 2 1 0 1 1 2 1 0 1 2 2 2 5 2 1 9 0 0 1 1 0 0 0 0 0 Malnutrition      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 1 / 14 (7.14%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 1 / 42 (2.38%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 Iron deficiency      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 1 / 12 (8.33%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 0 / 35 (0.00%) 0 / 16 (0.00%) 0 / 42 (0.00%) 0 / 32 (0.00%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 1 / 26 (3.85%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 Vitamin D deficiency      subjects affected / exposed 0 / 10 (0.00%) 0 / 7 (0.00%) 0 / 1 (0.00%) 0 / 1 (0.00%) 0 / 22 (0.00%) 0 / 18 (0.00%) 0 / 6 (0.00%) 0 / 18 (0.00%) 0 / 17 (0.00%) 0 / 12 (0.00%) 0 / 14 (0.00%) 0 / 14 (0.00%) 0 / 15 (0.00%) 2 / 35 (5.71%) 0 / 16 (0.00%) 0 / 42 (0.00%) 1 / 32 (3.13%) 0 / 41 (0.00%) 0 / 80 (0.00%) 0 / 17 (0.00%) 0 / 79 (0.00%) 0 / 9 (0.00%) 0 / 6 (0.00%) 0 / 37 (0.00%) 0 / 14 (0.00%) 0 / 1 (0.00%) 0 / 15 (0.00%) 0 / 26 (0.00%) 0 / 20 (0.00%) 0 / 1 (0.00%)      occurrences all number 0 0 0 0 0 0 0 0 0 0 0 0 0 2 0 0 1 0 0 0 0 0 0 0 0 0 0 0 0 0

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Substantial protocol amendments (globally)
Were there any global substantial amendments to the protocol? Yes
Date	Amendment
05 Apr 2016	Changes to the DLT criteria
13 Jul 2016	Incorporates a sub-study to perform an early assessment of the effect of BMS-986205 on the QTc interval.
14 Dec 2016	- Adds multiple dose expansion cohorts and ensured consistent dosing throughout each cohort. - Eliminated the Food Effect sub study from the global protocol (sub study will only open at sites in the United States). -Duration of study treatment has been changed from 24 weeks to approximately 1 year, with up to 12 cycles. - Inclusion criteria have been updated to include non-treatment naïve NSCLC subjects and subjects with sarcomas. - Guidelines for permanent discontinuation of study drugs have been updated.
27 Feb 2017	- RCC was added as an expansion cohort in Part 2. - Adds an evaluation of the safety, tolerability, and preliminary anti-tumor activity of the combination of BMS-986205, nivolumab, and ipilimumab in cohorts of melanoma, non-small cell lung cancer (NSCLC), and bladder cancer subjects.
29 Jun 2018	- Established HLH and DRESS syndrome as adverse events of special interest (AEOSI) requiring expedited reporting - Further evaluation of safety and initial efficacy exploration of nivolumab and ipilimumab on a Q4W/Q8W schedule in combination with BMS-986205 in a mixed tumor type cohort in Part 3. - Updating exclusion, dose delay, dose reduction, and drug discontinuation criteria, and increasing frequency of methemoglobin monitoring to at least monthly across all protocol parts
Interruptions (globally)
Were there any global interruptions to the trial? No
Limitations and caveats
Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
None reported

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