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Clinical Trial Results:
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors

Summary
EudraCT number	2012-002206-52
Trial protocol	BE GB DK
Global end of trial date	28 Feb 2020

Results information
Results version number	v2(current)
This version publication date	07 May 2021
First version publication date	13 Mar 2021
Other versions	v1
Version creation reason

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

CD-ON-MEDI4736-1108

ISRCTN number

US NCT number

NCT01693562

WHO universal trial number (UTN)

Sponsor organisation name

MedImmune, LLC

Sponsor organisation address

One MedImmune Way, Gaithersburg, United States, 20878

Public contact

Ashok Gupta, MedImmune, LLC, +1 3013981287, information.center@astrazeneca.com

Scientific contact

Ashok Gupta, MedImmune, LLC, +1 3013981287, information.center@astrazeneca.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

02 Apr 2020

Is this the analysis of the primary completion data?

Yes

Primary completion date

28 Feb 2020

Global end of trial reached?

Yes

Global end of trial date

28 Feb 2020

Was the trial ended prematurely?

Main objective of the trial

The main objectives of the study are: 1. To determine maximum tolerated dose or optimal biologic dose of MEDI4736 in dose-escalation phase 2. Safety profile of MEDI4736 in dose-escalation, dose-exploration, dose-expansion phases 3. Antitumor activity of MEDI4736 in dose-expansion phase in participants with programmed death ligand 1 (PD-L1) positive urothelial bladder cancer (UBC) who had received 1 line of prior therapy (2L+), in participants with non-squamous non-small cell lung cancer (NSCLC) who had received 2 or more lines of prior therapy (3L+), and in participants with squamous NSCLC who had received 1 line of prior therapy (2L+) and 2 or more lines of prior therapy (3L+). Antitumor activity was assessed by Blinded Independent Central Review (BICR) based on Response Evaluation Criteria in Solid Tumors (RECIST) version (v) 1.1.

Protection of trial subjects

The conduct of this clinical study met all local and regulatory requirements. The study was conducted in accordance with the ethical principles that have their origin in the Declaration of Helsinki and are consistent with International Conference on Harmonization guideline: Good Clinical Practice, and applicable regulatory requirements. Participants signed an informed consent form and could withdraw from the study at any time without any disadvantage and without having to provide a reason for this decision. Only investigators qualified by training and experience were selected as appropriate experts to investigate the study drug.

Background therapy

Evidence for comparator

Actual start date of recruitment

28 Aug 2012

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

5 Years

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Belgium: 29

Country: Number of subjects enrolled

Canada: 55

Country: Number of subjects enrolled

Germany: 29

Country: Number of subjects enrolled

France: 66

Country: Number of subjects enrolled

United Kingdom: 41

Country: Number of subjects enrolled

Italy: 47

Country: Number of subjects enrolled

Korea, Republic of: 73

Country: Number of subjects enrolled

Taiwan: 3

Country: Number of subjects enrolled

United States: 681

Worldwide total number of subjects

1024

EEA total number of subjects

171

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

570

From 65 to 84 years

448

85 years and over

Subject disposition

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Recruitment details

The study was conducted in Belgium, Canada, France, Germany, Italy, South Korea, Taiwan, UK, and USA.

Screening details

N=1022 participants were enrolled, not N=1024 indicated in participant flow. Discrepancy is due to duplicate reporting of n=2 NSCLC participants. Once in 10mg/kg dose-escalation cohort (total N=6) and again in with N=302 NSCLC participants from 10mg/kg dose expansion cohort (total N=304).

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)

Arm description

Participants received intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Durvalumab 0.1 mg/kg was administered as IV infusion Q2W for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)

Arm description

Participants received IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Durvalumab 0.3 mg/kg was administered as IV infusion Q2W for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Escalation Cohort (MEDI4736 1 mg/kg Q2W)

Arm description

Participants received IV infusion of MEDI4736 1 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Durvalumab 1 mg/kg was administered as IV infusion Q2W for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Escalation Cohort (MEDI4736 3 mg/kg Q2W)

Arm description

Participants received IV infusion of MEDI4736 3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Durvalumab 3 mg/kg was administered as IV infusion Q2W for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Escalation Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Durvalumab 10 mg/kg was administered as IV infusion Q2W for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Escalation Cohort (MEDI4736 15 mg/kg Q3W)

Arm description

Participants received IV infusion of MEDI4736 15 mg/kg every 3 weeks (Q3W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Durvalumab 15 mg/kg was administered as IV infusion Q3W for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Exploration Cohort (MEDI4736 20 mg/kg Q4W)

Arm description

Participants received IV infusion of MEDI4736 20 mg/kg every 4 weeks (Q4W) in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Durvalumab 20 mg/kg was administered as IV infusion Q4W for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with squamous cell carcinoma of the head and neck (SCCHN) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Expansion Non-SCCHN HPV+ Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with non-SCCHN human papilloma virus positive (Non-SCCHN HPV+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with non-small-cell lung cancer (NSCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with hepatocellular carcinoma (HCC Total) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with advance cutaneous melanoma (ACM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with uveal melanoma (UM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with gastroesophageal cancer (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with triple-negative breast cancer (TNBC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with pancreatic adenocarcinoma (PAC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with urothelial carcinoma (UC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with glioblastoma multiforme (GBM) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with ovarian cancer (OC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with soft- tissue sarcoma (STS) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with small-cell lung cancer (SCLC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with microsatellite instability (MSI)-high cancer received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)

Arm description

Participants with nasopharyngeal carcinoma (NPC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose- expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Arm type

Experimental

Investigational medicinal product name

Durvalumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Solution for infusion

Routes of administration

Intravenous use

Dosage and administration details

Number of subjects in period 1	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)	Escalation Cohort (MEDI4736 1 mg/kg Q2W)	Escalation Cohort (MEDI4736 3 mg/kg Q2W)	Escalation Cohort (MEDI4736 10 mg/kg Q2W)	Escalation Cohort (MEDI4736 15 mg/kg Q3W)	Exploration Cohort (MEDI4736 20 mg/kg Q4W)	Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)	Expansion Non-SCCHN HPV+ Cohort (MEDI4736 10 mg/kg Q2W)	Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)	Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)	Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)	Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)
Started	4	4	3	3	6	7	21	62	22	304	40	21	24	51	40	31	201	20	47	20	21	62	10
Completed	0	0	0	0	0	0	0	0	0	4	0	0	1	0	0	0	4	0	0	0	0	0	0
Not completed	4	4	3	3	6	7	21	62	22	300	40	21	23	51	40	31	197	20	47	20	21	62	10
Adverse event, serious fatal	1	1	-	1	1	1	8	14	8	88	10	5	7	19	8	13	71	2	8	1	9	14	4
Consent withdrawn by subject	-	1	-	-	-	2	2	16	2	54	2	2	3	5	16	7	40	4	8	3	1	8	1
Death	3	1	-	2	5	3	9	28	9	120	20	3	12	23	15	10	57	14	28	15	8	21	3
Unspecified	-	-	2	-	-	1	2	3	1	28	4	7	-	1	1	-	28	-	1	-	1	17	1
Lost to follow-up	-	1	1	-	-	-	-	1	2	10	4	4	1	3	-	1	1	-	2	1	2	2	1

Baseline characteristics

Top of page

Reporting group title

Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)

Reporting group description

Reporting group title

Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)

Reporting group description

Reporting group title

Escalation Cohort (MEDI4736 1 mg/kg Q2W)

Reporting group description

Reporting group title

Escalation Cohort (MEDI4736 3 mg/kg Q2W)

Reporting group description

Reporting group title

Escalation Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Escalation Cohort (MEDI4736 15 mg/kg Q3W)

Reporting group description

Reporting group title

Exploration Cohort (MEDI4736 20 mg/kg Q4W)

Reporting group description

Reporting group title

Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion Non-SCCHN HPV+ Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group values	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)	Escalation Cohort (MEDI4736 1 mg/kg Q2W)	Escalation Cohort (MEDI4736 3 mg/kg Q2W)	Escalation Cohort (MEDI4736 10 mg/kg Q2W)	Escalation Cohort (MEDI4736 15 mg/kg Q3W)	Exploration Cohort (MEDI4736 20 mg/kg Q4W)	Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)	Expansion Non-SCCHN HPV+ Cohort (MEDI4736 10 mg/kg Q2W)	Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)	Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)	Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)	Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)	Total
Number of subjects	4	4	3	3	6	7	21	62	22	304	40	21	24	51	40	31	201	20	47	20	21	62	10	1024
Age categorical
Units: Participants
In utero	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Adults (18-64 years)	2	0	1	2	6	4	12	41	19	146	26	12	14	33	35	16	77	16	30	15	9	47	7	570
From 65-84 years	2	4	2	1	0	3	9	20	3	156	14	9	10	18	5	15	122	4	16	5	12	15	3	448
85 years and over	0	0	0	0	0	0	0	1	0	2	0	0	0	0	0	0	2	0	1	0	0	0	0	6
Age Continuous
Units: years
arithmetic mean (standard deviation)	58.5 ( 9.0 )	68.0 ( 2.9 )	65.3 ( 19.3 )	57.0 ( 13.7 )	48.8 ( 9.7 )	55.9 ( 16.9 )	64.9 ( 9.6 )	58.2 ( 12.0 )	53.5 ( 10.2 )	63.8 ( 11.0 )	58.1 ( 14.0 )	58.9 ( 14.3 )	61.3 ( 10.2 )	58.1 ( 11.5 )	51.2 ( 10.6 )	62.6 ( 10.2 )	66.1 ( 9.4 )	56.0 ( 13.0 )	59.7 ( 12.5 )	53.2 ( 15.7 )	64.8 ( 11.6 )	54.3 ( 13.4 )	54.0 ( 19.0 )	-
Sex: Female, Male
Units: Participants
Female	2	1	2	2	2	2	5	9	15	133	8	9	10	13	40	9	58	7	47	15	8	34	3	434
Male	2	3	1	1	4	5	16	53	7	171	32	12	14	38	0	22	143	13	0	5	13	28	7	590
Race/Ethnicity, Customized
Units: Subjects
American Indian or Alaskan 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
Asian	0	0	0	1	0	0	0	5	1	58	9	0	0	1	2	0	40	0	4	1	2	6	5	135
Black or African American	0	1	0	0	0	0	1	1	2	10	3	1	0	1	6	1	8	0	1	1	1	2	0	40
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	1	0	0	2	0	0	0	0	0	0	0	0	0	0	0	2	5
White	4	3	2	2	6	7	19	49	19	227	19	19	19	45	25	29	128	19	36	18	17	34	3	749
Other	0	0	0	0	0	0	1	2	0	4	1	0	0	0	1	1	5	1	0	0	1	4	0	21
Multiple	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	2
Missing	0	0	1	0	0	0	0	4	0	5	6	1	5	3	6	0	19	0	6	0	0	16	0	72
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	1	0	0	0	1	1	2	5	1	12	2	2	1	4	0	1	5	2	2	5	1	4	0	52
Not Hispanic or Latino	3	4	2	3	5	6	19	54	21	287	32	19	18	43	33	30	177	18	39	15	20	42	10	900
Unknown or Not Reported	0	0	1	0	0	0	0	3	0	5	6	0	5	4	7	0	19	0	6	0	0	16	0	72

End points

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Reporting group title

Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)

Reporting group description

Reporting group title

Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)

Reporting group description

Reporting group title

Escalation Cohort (MEDI4736 1 mg/kg Q2W)

Reporting group description

Reporting group title

Escalation Cohort (MEDI4736 3 mg/kg Q2W)

Reporting group description

Reporting group title

Escalation Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Escalation Cohort (MEDI4736 15 mg/kg Q3W)

Reporting group description

Reporting group title

Exploration Cohort (MEDI4736 20 mg/kg Q4W)

Reporting group description

Reporting group title

Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion Non-SCCHN HPV+ Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Subject analysis set title

Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W)

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-escalation or dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Subject analysis set title

Expansion Non-squamous NSCLC 3L+ Cohort

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants with non-squamous NSCLC who had received 2 or more lines of prior therapy (3L+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Subject analysis set title

Expansion Squamous NSCLC 3L+ Cohort

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants with squamous NSCLC who had received 2 or more lines of prior therapy (3L+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Subject analysis set title

Expansion Squamous NSCLC 2L+ Cohort

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants with squamous NSCLC who had received at least 1 line of prior therapy (2L+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Subject analysis set title

Expansion UC PD-L1 high 2L+ Cohort

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants with UC (post-platinum PD-L1 status high) who had received at least 1 line of prior therapy (2L+) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Subject analysis set title

Total Escalation/Exploration Cohort

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants received IV infusion of MEDI4736 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, and 10 mg/kg Q2W, and 15 mg/kg Q3W in the dose-escalation phase; and 20 mg/kg Q4W in the dose-exploration phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Subject analysis set title

Expansion UC PD-L1 low/Negative Cohort

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants with UC (PD-L1 status low/negative) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Subject analysis set title

Expansion UC Total Cohort

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants with UC (Total PD-L1 status - high, low/negative, and unknown) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Subject analysis set title

Expansion UC PD-L1 high Cohort

Subject analysis set type

Sub-group analysis

Subject analysis set description

Participants with UC (PD-L1 status high) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Primary: Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase

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End point title

Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase ^[1] ^[2]

End point description

A DLT was defined as any Grade 3 or higher treatment-related toxicity that occurred during the DLT-evaluation period including any >= Grade 3 colitis or >= Grade 3 immune-related adverse event (irAE; AEs of immune nature in the absence of a clear alternative etiology) including rash, pruritus, or diarrhea that did not downgrade to =< Grade 2 within 3 days after onset of the event despite maximal supportive care including systemic corticosteroids. The DLT-evaluation period for 0.1 to 10 mg/kg arms was from Day 1 to Day 28 of first dose and for 15 mg/kg arm was from Day 1 to Day 42 of first dose. Participants in DLT-evaluable population (participants in the dose-escalation phase who received at least 2 doses of study drug and completed safety follow-up through DLT-evaluable period or experienced any DLT during the DLT-evaluation period) were analysed.

End point type

Primary

End point timeframe

For MEDI4736 0.1 to MEDI4736 10 mg/kg arms: from Day 1 to Day 28 of first dose; for MEDI4736 15 mg/kg arm: from Day 1 to Day 42 of first dose

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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
[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: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)	Escalation Cohort (MEDI4736 1 mg/kg Q2W)	Escalation Cohort (MEDI4736 3 mg/kg Q2W)	Escalation Cohort (MEDI4736 10 mg/kg Q2W)	Escalation Cohort (MEDI4736 15 mg/kg Q3W)
Number of subjects analysed	4	4	3	3	6	7
Units: Participants	0	0	0	0	0	0

No statistical analyses for this end point

Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

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End point title

Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase ^[3] ^[4]

End point description

An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of these outcomes: death; initial or prolonged inpatient hospitalization; life threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. The TEAEs are defined as events present at baseline that worsened in intensity after administration of study drug or events absent at baseline that emerged after administration of study drug. As-treated population included all participants who received any dose of study drug. Participants enrolled in the 10 mg/kg Q2W Expansion and Escalation Cohort have been summarised as a total only because the safety profile of durvalumab monotherapy 10 mg/kg Q2W was manageable and generally consistent with the known safety profile of the anti-programmed cell death ligand (PD-L1/PD-1) drug class.

End point type

Primary

End point timeframe

From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)

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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
[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: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)	Escalation Cohort (MEDI4736 1 mg/kg Q2W)	Escalation Cohort (MEDI4736 3 mg/kg Q2W)	Escalation Cohort (MEDI4736 15 mg/kg Q3W)	Exploration Cohort (MEDI4736 20 mg/kg Q4W)	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W)
Number of subjects analysed	4	4	3	3	7	21	980
Units: Participants
Any TEAEs	3	4	3	3	7	21	963
Any TESAEs	1	2	1	1	3	13	536

No statistical analyses for this end point

Primary: Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion phase

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End point title

Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion phase ^[5] ^[6]

End point description

Number of participants with abnormal clinical laboratory parameters reported as TEAEs are reported. Abnormal clinical laboratory parameters defined as any abnormal finding during analysis of coagulation, urine, hematology, and serum chemistry. As-treated population included all participants who received any dose of study drug. Participants enrolled in the 10 mg/kg Q2W Expansion and Escalation Cohort have been summarised as a total only. This is because the safety profile of durvalumab monotherapy 10 mg/kg Q2W was manageable and generally consistent with the known safety profile of the anti-PD-L1/PD-1 drug class.

End point type

Primary

End point timeframe

From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)

Notes
[5] - 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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
[6] - 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: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)	Escalation Cohort (MEDI4736 1 mg/kg Q2W)	Escalation Cohort (MEDI4736 3 mg/kg Q2W)	Escalation Cohort (MEDI4736 15 mg/kg Q3W)	Exploration Cohort (MEDI4736 20 mg/kg Q4W)	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W)
Number of subjects analysed	4	4	3	3	7	21	980
Units: Participants
Anaemia	1	0	0	0	0	0	166
Thrombocytopenia	0	0	0	0	0	1	24
White blood cell count increased	0	0	0	0	0	1	3
Leukocytosis	0	0	0	0	0	0	20
Lymphocyte count decreased	0	0	0	0	0	0	12
Neutropenia	0	0	0	0	0	0	8
Leukopenia	0	0	0	0	0	0	7
Thrombocytosis	0	0	0	0	0	0	5
Iron deficiency anaemia	0	0	0	0	0	0	3
Haemoglobin decreased	0	0	0	0	0	0	2
Neutrophil count increased	0	0	0	0	0	0	2
Red blood cell count decreased	0	0	0	0	0	0	1
Anaemia of chronic disease	0	0	0	0	0	0	1
Eosinophilia	0	0	0	0	0	0	1
Haemolysis	0	0	0	0	0	0	1
Leukostasis syndrome	0	0	0	0	0	0	1
Immune thrombocytopenic purpura	0	0	0	0	0	0	1
International normalised ratio increased	0	0	0	0	0	0	16
Activated partial thromboplastin time prolonged	0	0	0	0	0	0	15
Blood fibrinogen increased	0	0	0	0	0	0	8
Platelet count decreased	0	0	0	0	0	0	5
Disseminated intravascular coagulation	0	0	0	0	0	0	2
Prothrombin time prolonged	0	0	0	0	0	0	2
Activated partial thromboplastin time shortened	0	0	0	0	0	0	1
Coagulation factor increased	0	0	0	0	0	0	1
Coagulopathy	0	0	0	0	0	0	1
Alanine aminotransferase increased	0	0	1	0	1	2	77
Aspartate aminotransferase increased	0	0	1	0	1	2	99
Blood alkaline phosphatase increased	0	0	1	0	0	1	70
Blood bilirubin increased	0	0	0	0	0	1	42
Gamma-glutamyltransferase increased	0	0	0	0	0	2	71
Hyperbilirubinaemia	0	0	0	0	0	0	14
Transaminases increased	0	0	0	0	0	0	8
Blood lactate dehydrogenase increased	0	0	0	0	0	0	7
Hepatic function abnormal	0	0	0	0	0	0	6
Alanine aminotransferase decreased	0	0	0	0	0	0	1
Aspartate aminotransferase decreased	0	0	0	0	0	0	1
Blood albumin decreased	0	0	0	0	0	0	1
Hepatic enzyme increased	0	0	0	0	0	0	1
Liver function test increased	0	0	0	0	0	0	1
White blood cell count decreased	0	0	0	0	0	0	8
Neutrophil count decreased	0	0	0	0	0	0	5
Lymphopenia	0	0	0	0	0	0	5
Blood creatinine increased	0	1	1	0	0	0	46
Hyperuricaemia	0	0	0	0	0	0	22
Blood urea increased	0	0	0	0	0	0	10
Glomerular filtration rate decreased	0	0	0	0	0	0	2
Hypothyroidism	0	1	1	0	1	3	89
Hyperthyroidism	0	0	0	0	0	1	30
Blood thyroid stimulating hormone increased	0	0	0	0	0	0	16
Blood thyroid stimulating hormone decreased	0	0	0	0	0	0	5
Thyroxine decreased	0	0	0	0	0	0	2
Thyroxine free decreased	0	0	0	0	0	0	2
Thyroxine free increased	0	0	0	0	0	0	2
Tri-iodothyronine free decreased	0	0	0	0	0	0	2
Thyroxine increased	0	0	0	0	0	0	1
Tri-iodothyronine decreased	0	0	0	0	0	0	1
Tri-iodothyronine increased	0	0	0	0	0	0	1
Hyponatraemia	0	0	1	0	1	1	91
Hypomagnesaemia	0	0	0	0	0	1	55
Hypercalcaemia	0	0	0	0	0	0	47
Hyperglycaemia	0	0	1	0	0	0	32
Hypokalaemia	0	0	0	0	0	0	60
Hypocalcaemia	0	0	0	0	0	0	17
Hypophosphataemia	0	0	0	0	0	0	16
Hypertriglyceridaemia	0	0	0	0	0	0	13
Hypoglycaemia	0	0	0	0	0	0	10
Blood cholesterol increased	0	0	0	0	0	0	6
Blood magnesium decreased	0	0	0	0	0	0	5
Blood triglycerides increased	0	0	0	0	0	0	5
Blood glucose increased	0	0	0	0	0	0	4
Hypercholesterolaemia	0	0	0	0	0	0	4
Blood potassium increased	0	0	0	0	0	0	3
Blood chloride increased	0	0	0	0	0	0	2
Blood electrolytes decreased	0	0	0	0	0	0	2
Blood potassium decreased	0	0	0	0	0	0	2
Hyperphosphataemia	0	0	0	0	0	0	2
Protein total decreased	0	0	0	0	0	0	2
Protein urine present	0	0	0	0	0	0	2
Blood bicarbonate decreased	0	0	0	0	0	0	1
Blood chloride decreased	0	0	0	0	0	0	1
Blood sodium decreased	0	0	0	0	0	0	1
Hypermagnesaemia	0	0	0	0	0	0	1
Hypernatraemia	0	0	0	0	0	0	1
Hypochloraemia	0	0	0	0	0	0	1
Hypoproteinaemia	0	0	0	0	0	0	1
Hyperkalaemia	0	0	0	0	0	0	30

No statistical analyses for this end point

Primary: Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

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End point title

Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase ^[7] ^[8]

End point description

Number of participants with abnormal vital signs reported as TEAEs are reported. Abnormal vital signs are defined as any abnormal finding in the vital sign parameters (body weight, body temperature, blood pressure, pulse rate, and respiratory rate). As-treated population included all participants who received any dose of study drug. Participants enrolled in the 10 mg/kg Q2W Expansion and Escalation Cohort have been summarised as a total only. This is because the safety profile of durvalumab monotherapy 10 mg/kg Q2W was manageable and generally consistent with the known safety profile of the anti-PD-L1/PD-1 drug class.

End point type

Primary

End point timeframe

From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)

Notes
[7] - 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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
[8] - 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: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)	Escalation Cohort (MEDI4736 1 mg/kg Q2W)	Escalation Cohort (MEDI4736 3 mg/kg Q2W)	Escalation Cohort (MEDI4736 15 mg/kg Q3W)	Exploration Cohort (MEDI4736 20 mg/kg Q4W)	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W)
Number of subjects analysed	4	4	3	3	7	21	980
Units: Participants
Pyrexia	0	3	0	1	3	2	145
Weight decreased	0	0	0	0	0	2	79
Hypertension	0	1	0	1	0	0	31
Hypotension	0	0	0	0	0	1	36
Weight increased	0	0	0	0	0	0	22
Tachycardia	0	0	0	0	0	0	19
Sinus tachycardia	0	0	0	0	0	0	14
Arrhythmia	0	0	0	0	0	0	3
Sinus bradycardia	0	0	0	0	0	0	3
Heart rate increased	0	0	0	0	0	0	1
Heart rate irregular	0	0	0	0	0	0	1
Peak expiratory flow rate decreased	0	0	0	0	0	0	1

No statistical analyses for this end point

Primary: Number of Participants With Change From Baseline in QT/QTc Interval in Local Electrocardiogram in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

Top of page

End point title

Number of Participants With Change From Baseline in QT/QTc Interval in Local Electrocardiogram in the Dose-escalation, Dose-exploration, and Dose-expansion Phase ^[9] ^[10]

End point description

Number of participants with change from baseline in notable QT/QTc interval in local electrocardiogram are reported. The data for >0 participants with notable QT/QTc interval in local electrocardiogram from baseline are reported. As-treated population included all participants who received any dose of study drug were analysed. Participants with ECG readings available were evaluable for this analysis. Participants enrolled in the 10 mg/kg Q2W Expansion and Escalation Cohort have been summarised as a total only. This is because the safety profile of durvalumab monotherapy 10 mg/kg Q2W was manageable and generally consistent with the known safety profile of the anti-PD-L1/PD-1 drug class.

End point type

Primary

End point timeframe

From Baseline (Day 1) through 90 days after the last dose of study drug (approximately 5.25 years)

Notes
[9] - 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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.
[10] - 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: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)	Escalation Cohort (MEDI4736 1 mg/kg Q2W)	Escalation Cohort (MEDI4736 3 mg/kg Q2W)	Escalation Cohort (MEDI4736 15 mg/kg Q3W)	Exploration Cohort (MEDI4736 20 mg/kg Q4W)	Escalation/Expansion Cohort (Total MEDI4736 10 mg/kg Q2W)
Number of subjects analysed	4	4	3	3	7	21	980
Units: Participants
QTcF: > 30 (msec) n=0,1,1,1,0,0,63	0	1	0	0	0	0	4
QTcF: > 60 (msec) n=0,1,1,1,0,0,63	0	1	0	0	0	0	0
QTcB: > 30 (msec) n=2,2,2,1,2,9,288	0	0	0	0	0	4	17
QTcB: > 60 (msec) n=2,2,2,1,2,9,288	0	0	0	0	0	0	4
QTcB: > 90 (msec) n=4,4,3,3,7,21,288	0	0	0	0	0	0	3

No statistical analyses for this end point

Primary: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) in Participants With Non-squamous NSCLC who had Received 2 or More Prior Lines of Therapy in the Dose-expansion Phase

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End point title

Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) in Participants With Non-squamous NSCLC who had Received 2 or More Prior Lines of Therapy in the Dose-expansion Phase ^[11]

End point description

The ORR assessed by BICR is reported. The ORR is defined as best overall response (BOR) of confirmed complete response (CR) or confirmed partial response (PR) based on RECIST v1.1. The CR is disappearance of all target & non-target lesions & no new lesions. A confirmed CR is 2 CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is >= 30% decrease in sum of diameters of target lesions (compared to baseline) & no new nontarget lesion. A confirmed PR is 2 PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 wks with no evidence of progression in-between. Participants with non-squamous NSCLC in Full analysis set (FAS) population who had received 2 or more prior line of therapy were analysed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017.

End point type

Primary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.

End point values	Expansion Non-squamous NSCLC 3L+ Cohort
Number of subjects analysed	68
Units: Percentage of participants
number (confidence interval 95%)	10.3 (4.2 to 20.1)

No statistical analyses for this end point

Primary: ORR Assessed by BICR in Participants With Squamous NSCLC who had Received 1 and 2 or More Prior Lines of Therapy in the Dose-expansion Phase

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End point title

ORR Assessed by BICR in Participants With Squamous NSCLC who had Received 1 and 2 or More Prior Lines of Therapy in the Dose-expansion Phase ^[12]

End point description

The ORR assessed by BICR in participants with squamous NSCLC who had received 1 and 2 or more prior lines of therapy is reported. The ORR is defined as BOR of confirmed CR or confirmed PR based on RECIST v1.1. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between. Participants with squamous NSCLC in FAS population who had received 1 and 2 or more prior line of therapy were analysed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017.

End point type

Primary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Notes
[12] - 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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.

End point values	Expansion Squamous NSCLC 3L+ Cohort	Expansion Squamous NSCLC 2L+ Cohort
Number of subjects analysed	62	117
Units: Percentage of participants
number (confidence interval 95%)	12.9 (5.7 to 23.9)	12.8 (7.4 to 20.3)

No statistical analyses for this end point

Primary: ORR Assessed by BICR in Participants With UC Post-platinum (Programmed Cell Death Ligand [PD-L1] Status High) who had Received at Least 1 Line of Prior Therapy (2L+) in the Dose-expansion Phase

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End point title

ORR Assessed by BICR in Participants With UC Post-platinum (Programmed Cell Death Ligand [PD-L1] Status High) who had Received at Least 1 Line of Prior Therapy (2L+) in the Dose-expansion Phase ^[13]

End point description

The ORR assessed by BICR in participants with UC post-platinum PD-L1 status high 2L+ is reported. The ORR is defined as BOR of confirmed CR or confirmed PR based on RECIST v1.1. The CR is disappearance of all target and non-target lesions and no new lesions. A confirmed CR is 2 CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is 2 PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 wks with no evidence of progression in-between. Participants with UC in FAS population with 2L+ post-platinum PD-L1 status high (>= 25% tumor cell membrane or >= 25% immune cell staining) were analysed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 wks by 16Oct2017.

End point type

Primary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

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: Statistical analysis was not applicable since there were no inferential statistics, only descriptive statistics were performed for this end point.

End point values	Expansion UC PD-L1 high 2L+ Cohort
Number of subjects analysed	98
Units: Percentage of participants
number (confidence interval 95%)	27.6 (19.0 to 37.5)

No statistical analyses for this end point

Secondary: Area Under the Serum Concentration-time Curve up to the Last Measurable Concentration (AUClast) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase

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End point title

Area Under the Serum Concentration-time Curve up to the Last Measurable Concentration (AUClast) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase ^[14]

End point description

Area under the concentration-time curve from time zero to the last measurable concentration (AUClast) of MEDI4736 is reported. Pharmacokinetics (PK) evaluable population included all participants who received any dose of study drug and had at least one postdose PK concentration. Non-compartmental PK analysis was conducted using the data from dose escalation and exploration phases only.

End point type

Secondary

End point timeframe

After the first dose between Day 0 and Day 15 (Day 1 [pre and post dose] and predose of Dose 2 for all cohorts; Days 3, 5, 10 for Cohorts 0.1mg/kg to 10 mg/kg; Days 3, 5, 10, 15 for Cohort 15 mg/kg; Day 15 for Cohort 20 mg/kg)

Notes
[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: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)	Escalation Cohort (MEDI4736 1 mg/kg Q2W)	Escalation Cohort (MEDI4736 3 mg/kg Q2W)	Escalation Cohort (MEDI4736 10 mg/kg Q2W)	Escalation Cohort (MEDI4736 15 mg/kg Q3W)	Exploration Cohort (MEDI4736 20 mg/kg Q4W)
Number of subjects analysed	4	4	3	3	5	7	18
Units: Day*µg/mL
geometric mean (geometric coefficient of variation)	5.144 ( 45.1 )	25.063 ( 65.5 )	130.546 ( 20.1 )	399.863 ( 21.7 )	1780.152 ( 39.1 )	2943.770 ( 36.3 )	4501.888 ( 23.1 )

No statistical analyses for this end point

Secondary: Maximum Serum Concentration (Cmax) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase

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End point title

Maximum Serum Concentration (Cmax) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase ^[15]

End point description

Maximum Serum Concentration (Cmax) of MEDI4736 is reported. PK evaluable population included all participants who received any dose of study drug and had at least one postdose PK concentration. Non-compartmental PK analysis was conducted using the data from dose escalation and exploration phases only.

End point type

Secondary

End point timeframe

Notes
[15] - 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: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)	Escalation Cohort (MEDI4736 1 mg/kg Q2W)	Escalation Cohort (MEDI4736 3 mg/kg Q2W)	Escalation Cohort (MEDI4736 10 mg/kg Q2W)	Escalation Cohort (MEDI4736 15 mg/kg Q3W)	Exploration Cohort (MEDI4736 20 mg/kg Q4W)
Number of subjects analysed	4	4	3	3	5	7	18
Units: µg/mL
geometric mean (geometric coefficient of variation)	2.780 ( 22.1 )	7.969 ( 23.0 )	22.773 ( 11.3 )	70.807 ( 17.0 )	293.540 ( 23.4 )	427.085 ( 25.5 )	416.051 ( 23.9 )

No statistical analyses for this end point

Secondary: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI4736 in the Dose-escalation, Dose-exploration Phase, and Dose-expansion Phase.

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End point title

Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI4736 in the Dose-escalation, Dose-exploration Phase, and Dose-expansion Phase. ^[16]

End point description

Number of participants with positive ADA titer to MEDI4736 are reported. Treatment-boosted ADA is defined as baseline positive ADA titer that was boosted to a 4-fold or higher level following drug administration; persistent positive is defined as positive at >= 2 post-baseline assessments (with >= 16 weeks between first and last positive) or positive at last post-baseline assessment; and transient positive is defined as having at least one post-baseline ADA-positive assessment and not fulfilling the condition of persistent positive. ADA evaluable population included all participants who received any dose of study drug, had non-missing baseline (before Day 1) ADA, and at least one non-missing post-baseline ADA results.

End point type

Secondary

End point timeframe

Escalation: Day1 of Dose(D)1 & D3, even numbered doses after D4; Exploration: Day1 of D1 & D2, even numbered doses after D2; Expansion: Day1 of D1, every 12 weeks since D3; all phases: till EOT, 30 days and 3 and 6 months post last dose (~5.25 years)

Notes
[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: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)	Expansion Non-SCCHN HPV+ Cohort (MEDI4736 10 mg/kg Q2W)	Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)	Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)	Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)	Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)	Total Escalation/Exploration Cohort
Number of subjects analysed	56	17	257	37	17	21	38	33	26	148	17	41	19	15	58	6	45
Units: Participants
Positive post-baseline	1	0	6	0	0	1	0	1	0	7	0	2	1	0	2	0	4
Treatment-boosted	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Persistent positive	1	0	4	1	0	1	0	1	1	5	0	0	1	0	1	0	2
Transient positive	0	0	2	0	0	0	0	0	0	3	0	2	0	0	1	0	2

No statistical analyses for this end point

Secondary: Number of Participants With Best Overall Response (BOR) Assessed by BICR in NSCLC and SCCHN cohort in the Dose-expansion Phase

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End point title

Number of Participants With Best Overall Response (BOR) Assessed by BICR in NSCLC and SCCHN cohort in the Dose-expansion Phase ^[17]

End point description

The BOR assessed by BICR in NSCLC and SCCHN cohort is reported. The BOR includes CR, PR, stable disease (SD), progressive disease (PD), & non-evaluable (NE). The CR is disappearance of all target & nontarget lesions & no new lesions. The PR is >= 30% decrease in the sum of diameters of target lesions (compared to baseline [BL]) & no new nontarget lesion. The PD is atleast 20% decrease in sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is when no or only a subset of lesion measurements are made at an assessment. Participants in FAS population with NSCLC and SCCHN were analysed. FAS population included all participants who received any dose of study drug, had measurable disease at BL (Day 1) per BICR and were followed for at least 24 wks by 16Oct2017.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Notes
[17] - 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: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)	Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)
Number of subjects analysed	55	275
Units: Participants
CR	0	3
PR	4	39
SD	10	80
PD	31	110
NE	10	43

No statistical analyses for this end point

Secondary: Number of Participants With BOR Assessed by Investigator in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

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End point title

Number of Participants With BOR Assessed by Investigator in the Dose-escalation, Dose-exploration, and Dose-expansion Phase ^[18]

End point description

The BOR assessed by investigator based on RECIST v1.1 is reported. The BOR includes CR, PR, SD, PD, and NE. The CR is defined as disappearance of all target and non-target lesions and no new lesions. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The PD is defined at least 20% decrease in the sum of diameters of target lesions (compared to baseline) and/or new lesion. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The NE is defined as either when no or only a subset of lesion measurements are made at an assessment. As-treated population included all participants who received any dose of study drug. One participant from non-SCCHN HPV positive cohort had non-evaluable disease at baseline.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Notes
[18] - 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: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)	Expansion Non-SCCHN HPV+ Cohort (MEDI4736 10 mg/kg Q2W)	Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)	Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)	Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)	Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)	Total Escalation/Exploration Cohort
Number of subjects analysed	62	22	304	40	21	24	51	40	31	201	20	47	20	21	62	10	48
Units: Participants
CR	1	1	5	0	1	0	1	0	0	18	0	1	0	0	3	0	1
PR	6	2	49	4	2	1	1	1	1	24	0	2	2	2	12	3	4
SD	14	7	102	22	9	8	17	8	6	45	5	18	8	4	27	2	18
PD	33	9	103	12	5	12	21	25	17	81	14	22	8	9	15	3	18
NE	8	2	43	2	4	3	11	6	7	33	1	4	2	6	5	2	7
Not applicable	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Duration of Response (DoR) Assessed by BICR in NSCLC and SCCHN cohort in the Dose-expansion Phase

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End point title

Duration of Response (DoR) Assessed by BICR in NSCLC and SCCHN cohort in the Dose-expansion Phase ^[19]

End point description

DoR assessed by BICR is reported, which is duration from 1st documentation of objective response (OR) (confirmed 2 CRs [disappearance of all target and non-target lesions and no new lesions] or confirmed 2 PRs [>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion]) to 1st documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. 2 CRs and/or 2 PRs should be separated by at least 28 days with no evidence of progression in-between. DoR was estimated using Kaplan-Meier method. Arbitrary number 99999 signified upper limit of CI, which was not derived due to insufficient events being observed at time of analysis. Participants in FAS population (participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 wks by 16Oct2017) with NSCLC and SCCHN were analysed. DoR was analysed for those participants who achieved OR.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Notes
[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: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)	Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)
Number of subjects analysed	4	42
Units: Months
median (confidence interval 95%)	12.37 (3.5 to 99999)	17.74 (5.6 to 38.0)

No statistical analyses for this end point

Secondary: DoR assessed by Investigator in the Dose-expansion Phase

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End point title

DoR assessed by Investigator in the Dose-expansion Phase ^[20]

End point description

The DoR assessed by investigator is reported which is defined as the duration from the first documentation of OR (confirmed 2 CRs or confirmed 2 PRs) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The 2 CRs and/or 2 PRs should be separated by at least 28 days with no evidence of progression in-between. The DoR was estimated using Kaplan-Meier method. The arbitrary numbers 0.9999, 99999, & 99.999 signified the lower limit and upper limit of confidence interval, and median, respectively, which were not derived due to insufficient events being observed at the time of the analysis. As-treated population included all participants who received any dose of study drug. The DoR was analysed for those participants who achieved OR.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

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: Only those baseline period arms for which analysis was planned were reported in the end point.

Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)

Expansion Non-SCCHN HPV+ Cohort (MEDI4736 10 mg/kg Q2W)

Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)

Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)

Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)

Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)

Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)

Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)

Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)

Number of subjects analysed

0 ^[21]

Units: Months

median (confidence interval 95%)

19.71 (1.9 to 44.0)

14.75 (12.8 to 99999)

9.95 (8.3 to 16.4)

16.20 (7.2 to 99999)

99.999 (7.9 to 99999)

9.23 (0.9999 to 99999)

99.999 (0.9999 to 99999)

5.36 (0.9999 to 99999)

99.999 (14.6 to 99999)

( to )

24.87 (4.8 to 24.9)

7.92 (6.1 to 9.7)

23.51 (14.6 to 32.4)

26.91 (12.7 to 99999)

8.64 (4.4 to 16.3)

Notes
[21] - No participants achieved OR.

No statistical analyses for this end point

Secondary: Disease Control Rate (DCR) Assessed by BICR in NSCLC and SCCHN cohort in the Dose-expansion Phase

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End point title

Disease Control Rate (DCR) Assessed by BICR in NSCLC and SCCHN cohort in the Dose-expansion Phase ^[22]

End point description

Percentage of participants with DCR assessed by BICR is reported. The DCR is defined as a BOR of confirmed CR, confirmed PR, or SD based on RECIST v1.1. A confirmed CR is 2 CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is 2 PRs (>= 30% decrease in sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. Participants in FAS population with NSCLC and SCCHN were analysed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

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: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)	Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)
Number of subjects analysed	55	275
Units: Percentage of participants
number (confidence interval 95%)	25.5 (14.7 to 39.0)	44.4 (38.4 to 50.5)

No statistical analyses for this end point

Secondary: DCR Assessed by Investigator in the Dose-expansion Phase

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End point title

DCR Assessed by Investigator in the Dose-expansion Phase ^[23]

End point description

The DCR assessed by investigator is reported. Disease control is defined as a BOR of confirmed CR, confirmed PR, or SD based on RECIST v1.1. A confirmed CR is 2 CRs (disappearance of all target and non-target lesions and no new lesions) that were separated by at least 28 days with no evidence of progression in-between. A confirmed PR is 2 PRs (>= 30% decrease in the sum of diameters of target lesions compared to baseline and no new non-target lesion) or an un-confirmed PR and an unconfirmed CR that were separated by at least 28 days with no evidence of progression in-between. The SD is defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression. The arbitrary numbers -0.9999 and 99999 signified the lower limit and upper limit of CI, which were not derived due to insufficient events being observed at the time of the analysis. As-treated population included all participants who received any dose of study drug.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Notes
[23] - 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: Only those baseline period arms for which analysis was planned were reported in the end point.

Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)

Expansion Non-SCCHN HPV+ Cohort (MEDI4736 10 mg/kg Q2W)

Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)

Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)

Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)

Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)

Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)

Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)

Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)

Number of subjects analysed

302

201

Units: Percentage of participants

number (confidence interval 95%)

33.9 (22.3 to 47.0)

45.5 (25.7 to 70.2)

51.7 (45.9 to 57.4)

65.0 (48.3 to 79.4)

57.1 (34.0 to 78.2)

37.5 (18.8 to 59.4)

37.3 (24.1 to 51.9)

22.5 (10.8 to 38.5)

22.6 (9.6 to 41.1)

43.3 (36.3 to 50.4)

0 (-0.9999 to 99999)

44.7 (30.2 to 59.9)

50.0 (27.2 to 72.8)

28.6 (11.3 to 52.2)

67.7 (54.7 to 79.1)

50.0 (18.7 to 81.3)

No statistical analyses for this end point

Secondary: Progression-free Survival (PFS) Assessed by BICR in NSCLC cohort in the Dose-expansion Phase

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End point title

Progression-free Survival (PFS) Assessed by BICR in NSCLC cohort in the Dose-expansion Phase ^[24]

End point description

The PFS assessed by BICR in NSCLC cohort is reported. The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method. Participants in As-treated population with NSCLC were analysed. As-treated population included all participants who received any dose of study drug.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Notes
[24] - 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: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)
Number of subjects analysed	304
Units: Percentage of participants
median (confidence interval 95%)	2.1 (1.5 to 2.6)

No statistical analyses for this end point

Secondary: PFS Assessed by BICR in SCCHN cohort in the Dose-expansion Phase

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End point title

PFS Assessed by BICR in SCCHN cohort in the Dose-expansion Phase ^[25]

End point description

The PFS assessed by BICR in SCCHN cohort is reported. The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method. Participants in FAS population with SCCHN were analyzed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Notes
[25] - 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: Only those baseline period arms for which analysis was planned were reported in the end point.

End point values	Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)
Number of subjects analysed	62
Units: Percentage of participants
median (confidence interval 95%)	1.4 (1.3 to 1.5)

No statistical analyses for this end point

Secondary: PFS Assessed by Investigator in the Dose-expansion Phase

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End point title

PFS Assessed by Investigator in the Dose-expansion Phase ^[26]

End point description

The PFS assessed by the investigator is reported. The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method. As-treated population included all participants who received any dose of study drug.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Notes
[26] - 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: Only those baseline period arms for which analysis was planned were reported in the end point.

Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)

Expansion Non-SCCHN HPV+ Cohort (MEDI4736 10 mg/kg Q2W)

Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)

Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)

Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)

Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)

Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)

Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)

Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)

Number of subjects analysed

302

201

Units: Months

median (confidence interval 95%)

1.4 (1.4 to 1.6)

1.5 (1.2 to 5.6)

2.6 (1.9 to 3.2)

2.7 (1.4 to 5.3)

2.8 (1.2 to 9.1)

1.4 (1.3 to 4.6)

1.4 (1.2 to 2.4)

1.3 (1.2 to 1.6)

1.5 (1.3 to 1.7)

1.8 (1.4 to 2.6)

1.4 (1.2 to 2.3)

1.8 (1.4 to 2.7)

2.6 (1.4 to 3.0)

1.5 (0.9 to 1.8)

5.4 (2.9 to 11.1)

2.2 (0.7 to 5.7)

No statistical analyses for this end point

Secondary: Overall Survival (OS) in the Dose-Expansion Phase

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End point title

Overall Survival (OS) in the Dose-Expansion Phase ^[27]

End point description

The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method. The arbitrary numbers 99999 and 99.999 signified the data for upper limit of confidence interval and median, respectively, which were not derived due to insufficient events being observed at the time of the analysis. As-treated population included all participants who received any dose of study drug.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

Notes
[27] - 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: Only those baseline period arms for which analysis was planned were reported in the end point.

Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)

Expansion Non-SCCHN HPV+ Cohort (MEDI4736 10 mg/kg Q2W)

Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)

Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)

Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)

Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)

Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)

Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)

Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)

Number of subjects analysed

304

201

Units: Months

median (confidence interval 95%)

8.4 (5.7 to 12.3)

11.6 (3.0 to 22.8)

12.4 (9.3 to 15.2)

13.2 (6.3 to 23.0)

99.999 (15.1 to 99999)

8.4 (4.5 to 14.3)

4.9 (2.6 to 9.1)

5.5 (3.5 to 16.8)

5.7 (4.8 to 8.0)

10.5 (6.9 to 15.7)

10.0 (6.2 to 13.0)

11.1 (8.2 to 16.6)

15.8 (8.1 to 23.3)

4.8 (1.3 to 10.4)

24.1 (12.4 to 37.1)

16.1 (0.9 to 99999)

No statistical analyses for this end point

Secondary: ORR Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

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End point title

ORR Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

End point description

The ORR assessed by BICR in UC cohort is reported. The ORR is BOR of confirmed CR (2 CRs separated by at least 28 days with no evidence of progression in-between) or confirmed PR (2 PRs or an un-confirmed PR & an un-confirmed CR separated by at least 4 wks with no evidence of progression in-between) based on RECIST v1.1. The CR is disappearance of all target and non-target lesions and no new lesions. The PR is >= 30% decrease in sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. The UC cohort participants with PD-L1 status as low/negative (<25% tumor cell membrane and <25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (>= 25% tumor cell membrane or >=25% immune cell staining) included in the FAS population were analysed. FAS population included all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 weeks by 16Oct2017.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

End point values	Expansion UC PD-L1 low/Negative Cohort	Expansion UC Total Cohort	Expansion UC PD-L1 high Cohort
Number of subjects analysed	85	199	101
Units: Percentage of participants
number (confidence interval 95%)	5.9 (1.9 to 13.2)	17.6 (12.6 to 23.6)	27.7 (19.3 to 37.5)

No statistical analyses for this end point

Secondary: ORR Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

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End point title

ORR Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

End point description

The ORR assessed by the investigator in UC cohort is reported. The ORR is defined as BOR of confirmed CR or confirmed PR based on RECIST v1.1. A confirmed CR is defined as two CRs that were separated by at least 28 days with no evidence of progression in-between. The PR is defined as >= 30% decrease in the sum of diameters of target lesions (compared to baseline) and no new nontarget lesion. A confirmed PR is defined as two PRs or an un-confirmed PR and an un-confirmed CR that were separated by at least 4 weeks with no evidence of progression in-between. The UC cohort participants with PD-L1 status as low/negative (<25% tumor cell membrane and <25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (>= 25% tumor cell membrane or >=25% immune cell staining) included in the As-treated population were analysed. As-treated population included all participants who received any dose of study drug.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

End point values	Expansion UC PD-L1 low/Negative Cohort	Expansion UC Total Cohort	Expansion UC PD-L1 high Cohort
Number of subjects analysed	86	201	102
Units: Percentage of participants
number (confidence interval 95%)	7.0 (2.6 to 14.6)	20.9 (15.5 to 27.2)	33.3 (24.3 to 43.4)

No statistical analyses for this end point

Secondary: DoR Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

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End point title

DoR Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

End point description

The DoR assessed by BICR in UC cohort is reported. The DoR is the duration from the first documentation of OR (confirmed 2 CRs or confirmed 2 PRs) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The 2 CRs and/or 2 PRs should be separated by at least 28 days with no evidence of progression in-between. The arbitrary numbers 99999 & 99.999 signified upper limit of confidence interval and median, respectively, which were not derived due to insufficient events being observed at the time of the analysis. The DoR was estimated using Kaplan-Meier method. The UC cohort participants with PD-L1 status as low/negative, total, and high included in the FAS population (participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 wks by 16Oct2017) were analysed. The DoR was analysed for those participants who achieved OR.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

End point values	Expansion UC PD-L1 low/Negative Cohort	Expansion UC Total Cohort	Expansion UC PD-L1 high Cohort
Number of subjects analysed	5	35	28
Units: Months
median (confidence interval 95%)	12.25 (8.6 to 99999)	99.999 (16.0 to 99999)	99.999 (16.0 to 99999)

No statistical analyses for this end point

Secondary: DoR Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

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End point title

DoR Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

End point description

The DoR assessed by investigator in UC cohort is reported. The DoR is the duration from the first documentation of OR (confirmed 2 CRs or confirmed 2 PRs) to the first documented disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The 2 CRs and/or 2 PRs should be separated by at least 28 days with no evidence of progression in-between. The DoR was estimated using Kaplan-Meier method. The arbitrary number 99999 signified upper limit of CI, which was not derived due to insufficient events being observed at the time of the analysis. The UC cohort participants with PD-L1 status as low/negative (<25% tumor cell membrane and <25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (>= 25% tumor cell membrane or >=25% immune cell staining) included in the As-treated population (all participants who received any dose of study drug) were analysed. The DoR was analysed for those participants who achieved OR.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

End point values	Expansion UC PD-L1 low/Negative Cohort	Expansion UC Total Cohort	Expansion UC PD-L1 high Cohort
Number of subjects analysed	6	42	34
Units: Months
median (confidence interval 95%)	14.82 (6.9 to 99999)	19.71 (14.6 to 99999)	99.999 (12.3 to 99999)

No statistical analyses for this end point

Secondary: DCR Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

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End point title

DCR Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

End point description

The DCR assessed by BICR in UC cohort is reported, which is defined as BOR of confirmed CR (2 CRs [disappearance of all target and nontarget lesions and no new lesions]), confirmed PR (2 PRs [>= 30% decrease in sum of diameters of target lesions compared to baseline and no new nontarget lesion] or an unconfirmed PR and an unconfirmed CR), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression) based on RECIST v1.1. 2 CRs and/or 2 PRs should be separated by at least 28 days with no evidence of progression in-between. The UC cohort participants with PD-L1 status as low/negative, total, and high included in the FAS population (all participants who received any dose of study drug, had measurable disease at baseline (Day 1) per BICR and were followed for at least 24 wks by 16Oct2017) were analysed.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

End point values	Expansion UC PD-L1 low/Negative Cohort	Expansion UC Total Cohort	Expansion UC PD-L1 high Cohort
Number of subjects analysed	85	199	101
Units: Percentage of participants
number (confidence interval 95%)	21.2 (13.1 to 31.4)	35.2 (28.6 to 42.2)	43.6 (33.7 to 53.8)

No statistical analyses for this end point

Secondary: DCR Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

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End point title

DCR Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

End point description

Percentage of participants with DCR assessed by investigator in UC cohort is reported. The DCR is BOR of confirmed CR, (2 CRs [disappearance of all target and nontarget lesions and no new lesions]), confirmed PR (2 PRs [>= 30% decrease in sum of diameters of target lesions compared to baseline and no new nontarget lesion] or an unconfirmed PR and an unconfirmed CR), or SD (neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for disease progression) based on RECIST v1.1. 2 CRs and/or 2 PRs should be separated by at least 28 days with no evidence of progression in-between. The UC cohort participants with PD-L1 status as low/negative (<25% tumor cell membrane and <25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown) & high (>= 25% tumor cell membrane or >=25% immune cell staining) included in the As-treated population were analysed. As-treated population included all participants who received any dose of study drug.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

End point values	Expansion UC PD-L1 low/Negative Cohort	Expansion UC Total Cohort	Expansion UC PD-L1 high Cohort
Number of subjects analysed	86	201	102
Units: Percentage of participants
number (confidence interval 95%)	30.2 (20.8 to 41.1)	43.3 (36.3 to 50.4)	53.9 (43.8 to 63.8)

No statistical analyses for this end point

Secondary: PFS Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

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End point title

PFS Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

End point description

The PFS assessed by BICR in UC cohort is reported. The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method. The UC cohort participants with PD-L1 status as low/negative (<25% tumor cell membrane and <25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (>= 25% tumor cell membrane or >=25% immune cell staining) included in the As-treated population were analysed. As-treated population included all participants who received any dose of study drug.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

End point values	Expansion UC PD-L1 low/Negative Cohort	Expansion UC Total Cohort	Expansion UC PD-L1 high Cohort
Number of subjects analysed	86	201	102
Units: Months
median (confidence interval 95%)	1.4 (1.3 to 1.5)	1.5 (1.4 to 1.8)	1.9 (1.4 to 2.7)

No statistical analyses for this end point

Secondary: PFS Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

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End point title

PFS Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

End point description

The PFS assessed by the investigator in UC cohort is reported. The PFS is defined as the time from the start of study treatment until the first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. The PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method. The UC cohort participants with PD-L1 status as low/negative (<25% tumor cell membrane and <25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (>= 25% tumor cell membrane or >=25% immune cell staining) included in the As-treated population were analysed. As-treated population included all participants who received any dose of study drug.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

End point values	Expansion UC PD-L1 low/Negative Cohort	Expansion UC Total Cohort	Expansion UC PD-L1 high Cohort
Number of subjects analysed	86	201	102
Units: Months
median (confidence interval 95%)	1.4 (1.4 to 1.7)	1.8 (1.4 to 2.6)	2.8 (1.8 to 3.7)

No statistical analyses for this end point

Secondary: OS in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

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End point title

OS in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

End point description

The OS in UC cohort is reported. The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method. The arbitrary number 99999 signified upper limit of confidence interval which was not derived due to insufficient events being observed at the time of the analysis. The UC cohort participants with PD-L1 status as low/negative (<25% tumor cell membrane and <25% immune cell staining), total (PD-L1 high, PD-L1 low/negative, and PD-L1 unknown), and high (>= 25% tumor cell membrane or >=25% immune cell staining) included in the As-treated population were analysed. As-treated population included all participants who received any dose of study drug.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

End point values	Expansion UC PD-L1 low/Negative Cohort	Expansion UC Total Cohort	Expansion UC PD-L1 high Cohort
Number of subjects analysed	86	201	102
Units: Months
median (confidence interval 95%)	4.8 (3.3 to 8.1)	10.5 (6.9 to 15.7)	19.8 (9.3 to 99999)

No statistical analyses for this end point

Secondary: Adjusted Comparison of PFS by PD-L1 status in UC Cohort in the Dose-expansion Phase

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End point title

Adjusted Comparison of PFS by PD-L1 status in UC Cohort in the Dose-expansion Phase

End point description

The PFS by PD-L1 status in UC cohort is reported. The PFS estimates are adjusted for baseline eastern cooperative oncology group (ECOG), smoking status, race, gender, age, previous lines of therapy, and liver metastasis. 95% CIs based on log (-log(survival)). The PFS is the time from the start of study treatment until first documentation of disease progression based on RECIST v1.1 or death due to any cause, whichever occurred first. PD is defined as at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study; the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered PD. The PFS was estimated using Kaplan-Meier method. The UC cohort participants with PD-L1 status as high (>= 25% tumor cell membrane or >=25% immune cell staining) and low/negative (<25% tumor cell membrane and <25% immune cell staining) included in the As-treated population were analysed.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

End point values	Expansion UC PD-L1 low/Negative Cohort	Expansion UC PD-L1 high Cohort
Number of subjects analysed	39	61
Units: Months
median (confidence interval 95%)	1.5 (1.4 to 2.4)	2.6 (1.4 to 3.9)

Statistical Analysis 1

Comparison groups

Expansion UC PD-L1 high Cohort v Expansion UC PD-L1 low/Negative Cohort

Number of subjects included in analysis

100

Analysis specification

Pre-specified

Analysis type

^[28]

P-value

= 0.016

Method

Regression, Cox

Confidence interval

Notes
[28] - Other

Secondary: Adjusted Comparison of OS by PD-L1 status in UC Cohort in the Dose-expansion Phase

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End point title

Adjusted Comparison of OS by PD-L1 status in UC Cohort in the Dose-expansion Phase

End point description

The OS by PD-L1 status in UC cohort is reported. The OS estimates are adjusted for baseline ECOG, smoking status, race, gender, age, previous lines of therapy, and liver metastasis. 95% CIs based on log (-log(survival)). The OS is defined as the time from the start of study treatment until death due to any cause. The OS was estimated using Kaplan-Meier method. The arbitrary number 99999 signified upper limit of confidence interval which was not derived due to insufficient events being observed at the time of the analysis. The UC cohort participants with PD-L1 status as high (>= 25% tumor cell membrane or >=25% immune cell staining) and low/negative (<25% tumor cell membrane and <25% immune cell staining) included in the As-treated population were analysed. As-treated population included all participants who received any dose of study drug.

End point type

Secondary

End point timeframe

From Day 1 through disease progression, study withdrawal, or initiation of another anticancer therapy, whichever occurred first (approximately 5.25 years)

End point values	Expansion UC PD-L1 low/Negative Cohort	Expansion UC PD-L1 high Cohort
Number of subjects analysed	39	61
Units: Months
median (confidence interval 95%)	3.4 (2.4 to 14.3)	18.4 (7.8 to 99999)

Statistical Analysis 2

Comparison groups

Expansion UC PD-L1 high Cohort v Expansion UC PD-L1 low/Negative Cohort

Number of subjects included in analysis

100

Analysis specification

Pre-specified

Analysis type

^[29]

P-value

= 0.0046

Method

Regression, Cox

Confidence interval

Notes
[29] - Other

Adverse events

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Timeframe for reporting adverse events

From Day 1 through 90 days after the last dose of study drug (approximately 5.25 years)

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

22.1

Reporting group title

Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)

Reporting group description

Participants received intravenous (IV) infusion of MEDI4736 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Reporting group title

Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)

Reporting group description

Reporting group title

Escalation Cohort (MEDI4736 3 mg/kg Q2W)

Reporting group description

Reporting group title

Escalation Cohort (MEDI4736 1 mg/kg Q2W)

Reporting group description

Reporting group title

Escalation Cohort (MEDI4736 15 mg/kg Q3W)

Reporting group description

Reporting group title

Escalation Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Exploration Cohort (MEDI4736 20 mg/kg Q4W)

Reporting group description

Reporting group title

Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion Non-SCCHN Cohort HPV+ (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Participants with gastroesophageal (GEC) received IV infusion of MEDI4736 10 mg/kg Q2W in the dose-expansion phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurred first.

Reporting group title

Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Reporting group title

Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)

Reporting group description

Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)

Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)

Escalation Cohort (MEDI4736 3 mg/kg Q2W)

Escalation Cohort (MEDI4736 1 mg/kg Q2W)

Escalation Cohort (MEDI4736 15 mg/kg Q3W)

Escalation Cohort (MEDI4736 10 mg/kg Q2W)

Exploration Cohort (MEDI4736 20 mg/kg Q4W)

Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)

Expansion Non-SCCHN Cohort HPV+ (MEDI4736 10 mg/kg Q2W)

Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)

Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)

Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)

Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)

Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)

Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)

Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)

Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)

Total subjects affected by serious adverse events

subjects affected / exposed

1 / 4 (25.00%)

2 / 4 (50.00%)

1 / 3 (33.33%)

3 / 7 (42.86%)

3 / 6 (50.00%)

13 / 21 (61.90%)

30 / 62 (48.39%)

16 / 22 (72.73%)

163 / 304 (53.62%)

24 / 40 (60.00%)

12 / 24 (50.00%)

7 / 21 (33.33%)

26 / 51 (50.98%)

20 / 40 (50.00%)

117 / 201 (58.21%)

25 / 31 (80.65%)

9 / 20 (45.00%)

7 / 20 (35.00%)

26 / 47 (55.32%)

31 / 62 (50.00%)

14 / 21 (66.67%)

7 / 10 (70.00%)

number of deaths (all causes)

208

128

number of deaths resulting from adverse events

Neoplasms benign, malignant and unspecified (incl cysts and polyps)

ADENOCARCINOMA OF THE CERVIX

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

ADENOCARCINOMA PANCREAS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

2 / 21 (9.52%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

3 / 31 (9.68%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 3

0 / 0

ANAL CANCER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

3 / 22 (13.64%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

BLADDER CANCER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

45 / 201 (22.39%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 50

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 42

0 / 0

BLADDER CANCER STAGE IV

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

BLADDER TRANSITIONAL CELL CARCINOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

4 / 201 (1.99%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 4

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 3

0 / 0

BREAST CANCER METASTATIC

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

1 / 40 (2.50%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CANCER PAIN

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

3 / 201 (1.49%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

CERVIX CARCINOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

2 / 22 (9.09%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

CHOROID MELANOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

1 / 24 (4.17%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

COLON CANCER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

2 / 62 (3.23%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

COLORECTAL ADENOCARCINOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

COLORECTAL CANCER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

5 / 62 (8.06%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 6

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 5

0 / 0

ENDOMETRIAL CANCER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

GASTRIC CANCER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

4 / 51 (7.84%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 4

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 4

0 / 0

GASTROOESOPHAGEAL CANCER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

GLIOBLASTOMA MULTIFORME

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

2 / 20 (10.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

HEPATOCELLULAR CARCINOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

7 / 40 (17.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 8

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 6

0 / 0

INTRAOCULAR MELANOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

2 / 24 (8.33%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

LUNG ADENOCARCINOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

3 / 304 (0.99%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 3

0 / 0

LUNG CANCER METASTATIC

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

3 / 304 (0.99%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 3

0 / 0

LUNG NEOPLASM

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

LUNG NEOPLASM MALIGNANT

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

13 / 304 (4.28%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

1 / 21 (4.76%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 14

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 12

0 / 0

0 / 1

0 / 0

MALIGNANT MELANOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

2 / 21 (9.52%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

MALIGNANT NEOPLASM OF RENAL PELVIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

MALIGNANT PLEURAL EFFUSION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

METASTASES TO BLADDER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

METASTATIC CARCINOMA OF THE BLADDER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

METASTATIC GASTRIC CANCER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

METASTATIC MALIGNANT MELANOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

1 / 24 (4.17%)

2 / 21 (9.52%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 2

0 / 0

NASOPHARYNGEAL CANCER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

4 / 10 (40.00%)

occurrences causally related to treatment / all

0 / 0

0 / 5

deaths causally related to treatment / all

0 / 0

0 / 4

NEOPLASM SWELLING

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

NON-SMALL CELL LUNG CANCER

subjects affected / exposed

1 / 4 (25.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

1 / 6 (16.67%)

1 / 21 (4.76%)

0 / 62 (0.00%)

0 / 22 (0.00%)

47 / 304 (15.46%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 55

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

0 / 1

0 / 0

0 / 43

0 / 0

NON-SMALL CELL LUNG CANCER METASTATIC

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

OESOPHAGEAL ADENOCARCINOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

OESOPHAGEAL CANCER METASTATIC

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

2 / 51 (3.92%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

OESOPHAGEAL CARCINOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

3 / 51 (5.88%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 4

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 3

0 / 0

ONCOLOGIC COMPLICATION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 62 (1.61%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

OVARIAN CANCER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

7 / 47 (14.89%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 8

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 5

0 / 0

PANCREATIC CARCINOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

8 / 31 (25.81%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 9

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 8

0 / 0

PANCREATIC CARCINOMA METASTATIC

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

2 / 31 (6.45%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

PANCREATIC CARCINOMA STAGE IV

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

2 / 31 (6.45%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

PARANEOPLASTIC SYNDROME

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

PROSTATE CANCER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

SMALL CELL LUNG CANCER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

8 / 21 (38.10%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 13

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 8

0 / 0

SOFT TISSUE SARCOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 62 (1.61%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

SQUAMOUS CELL CARCINOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

SQUAMOUS CELL CARCINOMA OF HEAD AND NECK

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

6 / 62 (9.68%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 6

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 5

0 / 0

SQUAMOUS CELL CARCINOMA OF LUNG

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

4 / 304 (1.32%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 6

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 4

0 / 0

SQUAMOUS CELL CARCINOMA OF PHARYNX

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

2 / 62 (3.23%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

SQUAMOUS CELL CARCINOMA OF THE HYPOPHARYNX

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

2 / 62 (3.23%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

TRANSITIONAL CELL CANCER OF THE RENAL PELVIS AND URETER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

TRANSITIONAL CELL CARCINOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

8 / 201 (3.98%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 8

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 5

0 / 0

TRANSITIONAL CELL CARCINOMA METASTATIC

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

TRANSITIONAL CELL CARCINOMA RECURRENT

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

TRIPLE NEGATIVE BREAST CANCER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

2 / 40 (5.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

TUMOUR ASSOCIATED FEVER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

TUMOUR FLARE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

TUMOUR PAIN

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

3 / 201 (1.49%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

VULVAL CANCER METASTATIC

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Vascular disorders

EMBOLISM

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

4 / 304 (1.32%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

0 / 201 (0.00%)

1 / 31 (3.23%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 4

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

HAEMATOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPERTENSION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPOTENSION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 62 (1.61%)

0 / 22 (0.00%)

3 / 304 (0.99%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SUPERIOR VENA CAVA SYNDROME

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 62 (1.61%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

1 / 21 (4.76%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

VASCULAR OCCLUSION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

VENA CAVA THROMBOSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

VENOUS THROMBOSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

ASTHENIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

2 / 40 (5.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

2 / 201 (1.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

1 / 21 (4.76%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 2

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CHEST PAIN

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CHILLS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

COMPLICATION ASSOCIATED WITH DEVICE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

1 / 10 (10.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

DEATH

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 62 (1.61%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

2 / 40 (5.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

FATIGUE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

4 / 304 (1.32%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

2 / 201 (1.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

2 / 21 (9.52%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 4

0 / 1

0 / 0

0 / 2

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

GENERAL PHYSICAL HEALTH DETERIORATION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

3 / 304 (0.99%)

3 / 40 (7.50%)

1 / 24 (4.17%)

0 / 21 (0.00%)

1 / 51 (1.96%)

1 / 40 (2.50%)

7 / 201 (3.48%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

3 / 62 (4.84%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 6

0 / 5

0 / 1

0 / 0

0 / 2

0 / 11

0 / 0

0 / 2

0 / 5

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 3

0 / 2

0 / 0

0 / 1

0 / 5

0 / 0

0 / 1

0 / 2

0 / 0

MALAISE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

1 / 40 (2.50%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

MULTIPLE ORGAN DYSFUNCTION SYNDROME

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

1 / 10 (10.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

NON-CARDIAC CHEST PAIN

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

3 / 304 (0.99%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

OEDEMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

OEDEMA PERIPHERAL

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

2 / 304 (0.66%)

1 / 40 (2.50%)

1 / 24 (4.17%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

1 / 31 (3.23%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PAIN

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 62 (1.61%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

1 / 40 (2.50%)

0 / 201 (0.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PYREXIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

1 / 21 (4.76%)

3 / 62 (4.84%)

0 / 22 (0.00%)

3 / 304 (0.99%)

2 / 40 (5.00%)

2 / 24 (8.33%)

0 / 21 (0.00%)

1 / 51 (1.96%)

2 / 40 (5.00%)

3 / 201 (1.49%)

2 / 31 (6.45%)

0 / 20 (0.00%)

0 / 47 (0.00%)

3 / 62 (4.84%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 3

0 / 0

0 / 4

0 / 2

0 / 0

0 / 1

0 / 2

0 / 3

0 / 0

0 / 4

0 / 0

deaths causally related to treatment / all

0 / 0

Reproductive system and breast disorders

FEMALE GENITAL TRACT FISTULA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

VAGINAL DISCHARGE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

ACUTE RESPIRATORY FAILURE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 62 (1.61%)

0 / 22 (0.00%)

3 / 304 (0.99%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

BRONCHIAL OBSTRUCTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

CHRONIC OBSTRUCTIVE PULMONARY DISEASE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

5 / 304 (1.64%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 7

0 / 0

deaths causally related to treatment / all

0 / 0

COUGH

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

1 / 21 (4.76%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DYSPNOEA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 21 (0.00%)

4 / 62 (6.45%)

0 / 22 (0.00%)

23 / 304 (7.57%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

2 / 51 (3.92%)

2 / 40 (5.00%)

2 / 201 (1.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

3 / 20 (15.00%)

0 / 47 (0.00%)

3 / 62 (4.84%)

4 / 21 (19.05%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 5

0 / 0

0 / 24

0 / 2

0 / 0

0 / 2

0 / 3

0 / 0

0 / 3

0 / 0

0 / 3

0 / 6

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

DYSPNOEA EXERTIONAL

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

1 / 40 (2.50%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HAEMOPTYSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

2 / 62 (3.23%)

0 / 22 (0.00%)

2 / 304 (0.66%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

1 / 21 (4.76%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 4

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPOXIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

OBSTRUCTIVE AIRWAYS DISORDER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

OESOPHAGOBRONCHIAL FISTULA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PHARYNGEAL HAEMORRHAGE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 62 (1.61%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

PLEURAL EFFUSION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

9 / 304 (2.96%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

2 / 40 (5.00%)

2 / 201 (1.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

2 / 21 (9.52%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

1 / 9

0 / 0

0 / 2

0 / 1

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

PLEURITIC PAIN

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

3 / 304 (0.99%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

PNEUMONIA ASPIRATION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

4 / 304 (1.32%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 6

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PNEUMONITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

4 / 304 (1.32%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

3 / 4

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

1 / 1

0 / 0

PNEUMOTHORAX

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

2 / 304 (0.66%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 3

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

PULMONARY EMBOLISM

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

3 / 304 (0.99%)

0 / 40 (0.00%)

1 / 24 (4.17%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

2 / 201 (1.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

2 / 47 (4.26%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

PULMONARY HAEMORRHAGE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

2 / 304 (0.66%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

PULMONARY VENOUS THROMBOSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

RESPIRATORY DISTRESS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

1 / 24 (4.17%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

RESPIRATORY FAILURE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 62 (0.00%)

0 / 22 (0.00%)

8 / 304 (2.63%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

2 / 51 (3.92%)

1 / 40 (2.50%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 9

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 5

0 / 0

0 / 2

0 / 1

0 / 0

TRACHEAL STENOSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Psychiatric disorders

ANXIETY

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CONFUSIONAL STATE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

2 / 201 (1.00%)

0 / 31 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

MENTAL STATUS CHANGES

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

1 / 21 (4.76%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SUICIDE ATTEMPT

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Product issues

DEVICE DISLOCATION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DEVICE MALFUNCTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DEVICE OCCLUSION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Investigations

ALANINE AMINOTRANSFERASE INCREASED

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

ASPARTATE AMINOTRANSFERASE INCREASED

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

1 / 40 (2.50%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

1 / 21 (4.76%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

2 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

BLOOD ALKALINE PHOSPHATASE INCREASED

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

BLOOD BILIRUBIN INCREASED

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

2 / 201 (1.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

2 / 62 (3.23%)

1 / 21 (4.76%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

BLOOD CREATININE INCREASED

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

1 / 3 (33.33%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

1 / 24 (4.17%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

BLOOD ELECTROLYTES DECREASED

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

EASTERN COOPERATIVE ONCOLOGY GROUP PERFORMANCE STATUS WORSENED

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

GAMMA-GLUTAMYLTRANSFERASE INCREASED

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

INTERNATIONAL NORMALISED RATIO INCREASED

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

TRANSAMINASES INCREASED

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

1 / 24 (4.17%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Injury, poisoning and procedural complications

CONTUSION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

FALL

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

FEMORAL NECK FRACTURE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

FEMUR FRACTURE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

FRACTURE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HIP FRACTURE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

1 / 40 (2.50%)

1 / 24 (4.17%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

INFUSION RELATED REACTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

POST PROCEDURAL COMPLICATION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

SPINAL COMPRESSION FRACTURE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SPINAL FRACTURE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

TOXICITY TO VARIOUS AGENTS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

ACUTE CORONARY SYNDROME

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ANGINA PECTORIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

1 / 24 (4.17%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ATRIAL FIBRILLATION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 62 (0.00%)

0 / 22 (0.00%)

3 / 304 (0.99%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 3

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ATRIAL FLUTTER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

3 / 304 (0.99%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

1 / 21 (4.76%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 5

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ATRIOVENTRICULAR BLOCK FIRST DEGREE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CARDIAC ARREST

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

2 / 304 (0.66%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

CARDIAC FAILURE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CARDIAC FAILURE CONGESTIVE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

1 / 7 (14.29%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

CARDIAC TAMPONADE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CARDIO-RESPIRATORY ARREST

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

2 / 201 (1.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

CARDIOVASCULAR DISORDER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ISCHAEMIC CARDIOMYOPATHY

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

MYOCARDIAL INFARCTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

MYOCARDITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PALPITATIONS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PERICARDIAL EFFUSION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

3 / 304 (0.99%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

1 / 21 (4.76%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 4

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SINUS TACHYCARDIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SUPRAVENTRICULAR TACHYCARDIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

TRIFASCICULAR BLOCK

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

VENTRICULAR TACHYCARDIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nervous system disorders

APHASIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

1 / 21 (4.76%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ATAXIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

1 / 40 (2.50%)

0 / 201 (0.00%)

0 / 31 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

BASAL GANGLIA INFARCTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CAUDA EQUINA SYNDROME

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CEREBROVASCULAR ACCIDENT

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

1 / 62 (1.61%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

COGNITIVE DISORDER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DIZZINESS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DYSARTHRIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

FACIAL PARALYSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

2 / 304 (0.66%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

HEADACHE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HEMIANOPIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HEMIANOPIA HOMONYMOUS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HEMIPARESIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYDROCEPHALUS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ISCHAEMIC NEUROPATHY

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ISCHAEMIC STROKE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

MIGRAINE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

MONOPARESIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

NERVE COMPRESSION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

NERVOUS SYSTEM DISORDER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

3 / 20 (15.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

3 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

PARAESTHESIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

2 / 40 (5.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

1 / 21 (4.76%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PARTIAL SEIZURES

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

1 / 40 (2.50%)

0 / 201 (0.00%)

0 / 31 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PERIPHERAL MOTOR NEUROPATHY

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

1 / 6 (16.67%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PERIPHERAL SENSORY NEUROPATHY

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SEIZURE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

1 / 20 (5.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SPINAL CORD COMPRESSION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

1 / 40 (2.50%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

1 / 10 (10.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

SPINAL CORD OEDEMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

1 / 40 (2.50%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SYNCOPE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

TRANSIENT ISCHAEMIC ATTACK

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

2 / 304 (0.66%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

TRIGEMINAL NEURALGIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood and lymphatic system disorders

ANAEMIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

1 / 304 (0.33%)

0 / 40 (0.00%)

1 / 24 (4.17%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

3 / 201 (1.49%)

1 / 31 (3.23%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 4

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DISSEMINATED INTRAVASCULAR COAGULATION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

IMMUNE THROMBOCYTOPENIC PURPURA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

1 / 40 (2.50%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

3 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

1 / 1

0 / 0

LEUKOCYTOSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 62 (1.61%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

1 / 40 (2.50%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

LYMPH NODE PAIN

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

NEUTROPENIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

THROMBOCYTOPENIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

1 / 40 (2.50%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

THROMBOCYTOSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 62 (1.61%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

ABDOMINAL PAIN

subjects affected / exposed

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

1 / 6 (16.67%)

2 / 21 (9.52%)

0 / 62 (0.00%)

2 / 22 (9.09%)

3 / 304 (0.99%)

0 / 40 (0.00%)

1 / 24 (4.17%)

0 / 21 (0.00%)

2 / 51 (3.92%)

2 / 40 (5.00%)

5 / 201 (2.49%)

3 / 31 (9.68%)

0 / 20 (0.00%)

3 / 47 (6.38%)

3 / 62 (4.84%)

0 / 21 (0.00%)

1 / 10 (10.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 2

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

0 / 3

0 / 2

0 / 5

0 / 3

0 / 0

1 / 3

0 / 3

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

ABDOMINAL PAIN LOWER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ABDOMINAL PAIN UPPER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

1 / 6 (16.67%)

0 / 21 (0.00%)

0 / 62 (0.00%)

3 / 22 (13.64%)

2 / 304 (0.66%)

1 / 40 (2.50%)

1 / 24 (4.17%)

0 / 21 (0.00%)

0 / 51 (0.00%)

1 / 40 (2.50%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 3

0 / 2

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ASCITES

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

2 / 40 (5.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

3 / 51 (5.88%)

0 / 40 (0.00%)

0 / 201 (0.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

COLITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

4 / 304 (1.32%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

2 / 47 (4.26%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

4 / 5

0 / 0

1 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

COLITIS ISCHAEMIC

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

COLONIC FISTULA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CONSTIPATION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 62 (1.61%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

1 / 21 (4.76%)

0 / 51 (0.00%)

0 / 40 (0.00%)

2 / 201 (1.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

1 / 21 (4.76%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DIARRHOEA

subjects affected / exposed

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

1 / 21 (4.76%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

1 / 1

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DUODENAL OBSTRUCTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DUODENAL STENOSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DYSPHAGIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

4 / 304 (1.32%)

0 / 40 (0.00%)

0 / 24 (0.00%)

1 / 21 (4.76%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 4

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ENTEROVESICAL FISTULA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

FAECALOMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

GASTRIC PERFORATION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

GASTROINTESTINAL HAEMORRHAGE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

2 / 201 (1.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

HAEMATEMESIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

ILEUS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

INTESTINAL ISCHAEMIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

INTESTINAL OBSTRUCTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

INTESTINAL PERFORATION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

INTRA-ABDOMINAL HAEMORRHAGE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

1 / 21 (4.76%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

LARGE INTESTINAL OBSTRUCTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

LOWER GASTROINTESTINAL HAEMORRHAGE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

NAUSEA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

3 / 201 (1.49%)

1 / 31 (3.23%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 2

0 / 0

0 / 1

0 / 0

0 / 4

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PANCREATITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PROCTALGIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PROCTITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

RETROPERITONEAL HAEMORRHAGE

subjects affected / exposed

0 / 4 (0.00%)

1 / 3 (33.33%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

SMALL INTESTINAL OBSTRUCTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

2 / 201 (1.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 1

0 / 0

0 / 2

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

SMALL INTESTINAL PERFORATION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SUBILEUS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

UPPER GASTROINTESTINAL HAEMORRHAGE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

VARICES OESOPHAGEAL

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

VOMITING

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

2 / 304 (0.66%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

5 / 201 (2.49%)

2 / 31 (6.45%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 2

0 / 0

0 / 1

0 / 0

0 / 6

1 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

AUTOIMMUNE HEPATITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

2 / 201 (1.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

3 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

1 / 1

0 / 0

CHOLANGITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CHOLECYSTITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CHOLELITHIASIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CHRONIC HEPATIC FAILURE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

HEPATIC FAILURE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

2 / 24 (8.33%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

HEPATIC FUNCTION ABNORMAL

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

2 / 40 (5.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

1 / 2

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HEPATIC HAEMORRHAGE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HEPATIC VEIN THROMBOSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HEPATOBILIARY DISEASE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HEPATOCELLULAR INJURY

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPERBILIRUBINAEMIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

1 / 40 (2.50%)

1 / 24 (4.17%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

1 / 201 (0.50%)

1 / 31 (3.23%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 2

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

LIVER INJURY

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Skin and subcutaneous tissue disorders

ERYTHEMA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

ACUTE KIDNEY INJURY

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

1 / 24 (4.17%)

0 / 21 (0.00%)

3 / 51 (5.88%)

0 / 40 (0.00%)

8 / 201 (3.98%)

1 / 31 (3.23%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

0 / 3

0 / 0

1 / 9

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

AZOTAEMIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HAEMATURIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

2 / 201 (1.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

HYDRONEPHROSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

3 / 201 (1.49%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

HYDROURETER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PROTEINURIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

URETERIC OBSTRUCTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

URINARY BLADDER POLYP

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

URINARY TRACT OBSTRUCTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

3 / 201 (1.49%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 5

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

URINARY TRACT PAIN

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Endocrine disorders

ADRENAL INSUFFICIENCY

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPERTHYROIDISM

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

STEROID WITHDRAWAL SYNDROME

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

ARTHRALGIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

BACK PAIN

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 62 (0.00%)

1 / 22 (4.55%)

4 / 304 (1.32%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

1 / 40 (2.50%)

9 / 201 (4.48%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

1 / 62 (1.61%)

1 / 21 (4.76%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 4

0 / 0

0 / 1

0 / 10

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

BONE PAIN

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

2 / 304 (0.66%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

FLANK PAIN

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

2 / 201 (1.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

GROIN PAIN

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

MUSCULAR WEAKNESS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

MUSCULOSKELETAL CHEST PAIN

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

1 / 40 (2.50%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

MUSCULOSKELETAL PAIN

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

MYOSITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

NECK PAIN

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

PAIN IN EXTREMITY

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

1 / 21 (4.76%)

0 / 51 (0.00%)

1 / 40 (2.50%)

3 / 201 (1.49%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

PATHOLOGICAL FRACTURE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

POLYMYALGIA RHEUMATICA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

ABDOMINAL ABSCESS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

ABDOMINAL INFECTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

BACTERAEMIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

0 / 62 (0.00%)

1 / 22 (4.55%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

BARTHOLINITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

BRONCHITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CELLULITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CLOSTRIDIUM DIFFICILE COLITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

CLOSTRIDIUM DIFFICILE INFECTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DEVICE RELATED INFECTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 62 (1.61%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

2 / 201 (1.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DIVERTICULITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

2 / 304 (0.66%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

ERYSIPELAS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HERPES ZOSTER

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

INFECTED FISTULA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 62 (1.61%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

KIDNEY INFECTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

NECROTISING FASCIITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

OSTEOMYELITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PERITONITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PERITONITIS BACTERIAL

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PNEUMONIA

subjects affected / exposed

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

2 / 21 (9.52%)

2 / 62 (3.23%)

1 / 22 (4.55%)

21 / 304 (6.91%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

2 / 51 (3.92%)

1 / 40 (2.50%)

4 / 201 (1.99%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 20 (5.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

2 / 21 (9.52%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 4

0 / 1

2 / 29

0 / 0

0 / 2

0 / 1

0 / 5

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 2

0 / 0

POSTOPERATIVE WOUND INFECTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PULMONARY TUBERCULOSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

PYELONEPHRITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

RESPIRATORY TRACT INFECTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

2 / 304 (0.66%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

SEPSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

1 / 21 (4.76%)

2 / 62 (3.23%)

1 / 22 (4.55%)

6 / 304 (1.97%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

8 / 201 (3.98%)

1 / 31 (3.23%)

0 / 20 (0.00%)

1 / 20 (5.00%)

2 / 47 (4.26%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 3

0 / 2

0 / 8

0 / 1

0 / 0

0 / 1

0 / 0

0 / 10

0 / 1

0 / 0

0 / 1

0 / 2

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 2

0 / 0

0 / 2

0 / 0

SEPTIC SHOCK

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SINUSITIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

1 / 10 (10.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

STOMA SITE INFECTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

SUBCUTANEOUS ABSCESS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

UPPER RESPIRATORY TRACT INFECTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

2 / 304 (0.66%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

URINARY TRACT CANDIDIASIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

URINARY TRACT INFECTION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

1 / 22 (4.55%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

1 / 40 (2.50%)

9 / 201 (4.48%)

1 / 31 (3.23%)

0 / 20 (0.00%)

2 / 47 (4.26%)

2 / 62 (3.23%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 13

0 / 1

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

UROSEPSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Metabolism and nutrition disorders

DECREASED APPETITE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 62 (1.61%)

0 / 22 (0.00%)

0 / 304 (0.00%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

DEHYDRATION

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

1 / 3 (33.33%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

3 / 304 (0.99%)

1 / 40 (2.50%)

0 / 24 (0.00%)

1 / 21 (4.76%)

1 / 51 (1.96%)

2 / 40 (5.00%)

3 / 201 (1.49%)

2 / 31 (6.45%)

0 / 20 (0.00%)

1 / 47 (2.13%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 3

0 / 1

0 / 0

0 / 1

0 / 2

0 / 3

0 / 2

0 / 0

1 / 1

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

FAILURE TO THRIVE

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

1 / 304 (0.33%)

1 / 40 (2.50%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPERCALCAEMIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

2 / 62 (3.23%)

0 / 22 (0.00%)

3 / 304 (0.99%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

5 / 201 (2.49%)

0 / 31 (0.00%)

0 / 20 (0.00%)

1 / 47 (2.13%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 3

0 / 0

0 / 5

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPERGLYCAEMIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

1 / 10 (10.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

HYPERKALAEMIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

1 / 51 (1.96%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPERLIPASAEMIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPOKALAEMIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

1 / 31 (3.23%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

1 / 21 (4.76%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPOMAGNESAEMIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPONATRAEMIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

1 / 3 (33.33%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

1 / 62 (1.61%)

0 / 22 (0.00%)

1 / 304 (0.33%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

3 / 51 (5.88%)

0 / 40 (0.00%)

2 / 201 (1.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

2 / 20 (10.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 5

0 / 0

0 / 1

0 / 0

0 / 3

0 / 0

0 / 2

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

HYPOPHAGIA

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

LACTIC ACIDOSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

METABOLIC ACIDOSIS

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

1 / 201 (0.50%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

0 / 62 (0.00%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

TUMOUR LYSIS SYNDROME

subjects affected / exposed

0 / 4 (0.00%)

0 / 3 (0.00%)

0 / 7 (0.00%)

0 / 6 (0.00%)

0 / 21 (0.00%)

0 / 62 (0.00%)

0 / 22 (0.00%)

0 / 304 (0.00%)

0 / 40 (0.00%)

0 / 24 (0.00%)

0 / 21 (0.00%)

0 / 51 (0.00%)

0 / 40 (0.00%)

0 / 201 (0.00%)

0 / 31 (0.00%)

0 / 20 (0.00%)

0 / 47 (0.00%)

1 / 62 (1.61%)

0 / 21 (0.00%)

0 / 10 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)	Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)	Escalation Cohort (MEDI4736 3 mg/kg Q2W)	Escalation Cohort (MEDI4736 1 mg/kg Q2W)	Escalation Cohort (MEDI4736 15 mg/kg Q3W)	Escalation Cohort (MEDI4736 10 mg/kg Q2W)	Exploration Cohort (MEDI4736 20 mg/kg Q4W)	Expansion SCCHN Cohort (MEDI4736 10 mg/kg Q2W)	Expansion Non-SCCHN Cohort HPV+ (MEDI4736 10 mg/kg Q2W)	Expansion NSCLC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion HCC Total Cohort (MEDI4736 10 mg/kg Q2W)	Expansion UM Cohort (MEDI4736 10 mg/kg Q2W)	Expansion ACM Cohort (MEDI4736 10 mg/kg Q2W)	Expansion GEC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion TNBC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion UC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion PAC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion GBM Cohort (MEDI4736 10 mg/kg Q2W)	Expansion STS Cohort (MEDI4736 10 mg/kg Q2W)	Expansion OC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion MSI-high Cancer Cohort (MEDI4736 10 mg/kg Q2W)	Expansion SCLC Cohort (MEDI4736 10 mg/kg Q2W)	Expansion NPC Cohort (MEDI4736 10 mg/kg Q2W)
Total subjects affected by non serious adverse events
subjects affected / exposed	3 / 4 (75.00%)	4 / 4 (100.00%)	3 / 3 (100.00%)	3 / 3 (100.00%)	7 / 7 (100.00%)	6 / 6 (100.00%)	20 / 21 (95.24%)	61 / 62 (98.39%)	22 / 22 (100.00%)	293 / 304 (96.38%)	40 / 40 (100.00%)	22 / 24 (91.67%)	19 / 21 (90.48%)	50 / 51 (98.04%)	40 / 40 (100.00%)	196 / 201 (97.51%)	31 / 31 (100.00%)	18 / 20 (90.00%)	20 / 20 (100.00%)	46 / 47 (97.87%)	57 / 62 (91.94%)	19 / 21 (90.48%)	10 / 10 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
CANCER PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	3 / 304 (0.99%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	3 / 40 (7.50%)	4 / 201 (1.99%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	3	0	0	0	0	3	6	0	0	0	0	0	0	0
PERITUMOURAL OEDEMA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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	0
TUMOUR HAEMORRHAGE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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	0
TUMOUR PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	4 / 304 (1.32%)	0 / 40 (0.00%)	0 / 24 (0.00%)	2 / 21 (9.52%)	1 / 51 (1.96%)	0 / 40 (0.00%)	10 / 201 (4.98%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	4	0	0	2	1	0	12	0	0	0	1	2	0	0
Vascular disorders
DEEP VEIN THROMBOSIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 62 (0.00%)	1 / 22 (4.55%)	3 / 304 (0.99%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	3 / 201 (1.49%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	1	0	1	3	1	0	0	0	0	3	0	0	0	0	0	0	0
HOT FLUSH
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	4 / 304 (1.32%)	2 / 40 (5.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	1 / 51 (1.96%)	0 / 40 (0.00%)	3 / 201 (1.49%)	0 / 31 (0.00%)	0 / 20 (0.00%)	3 / 20 (15.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	4	2	0	1	1	0	3	0	0	3	1	1	0	0
HYPERTENSION
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	11 / 304 (3.62%)	1 / 40 (2.50%)	0 / 24 (0.00%)	1 / 21 (4.76%)	2 / 51 (3.92%)	1 / 40 (2.50%)	7 / 201 (3.48%)	0 / 31 (0.00%)	3 / 20 (15.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	2 / 62 (3.23%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	1	3	0	0	0	0	0	0	16	1	0	1	2	2	13	0	3	1	0	2	1	0
HYPOTENSION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 62 (1.61%)	0 / 22 (0.00%)	12 / 304 (3.95%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	10 / 201 (4.98%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	3 / 62 (4.84%)	2 / 21 (9.52%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0	12	1	0	0	1	0	12	0	0	0	1	3	3	0
LYMPHOEDEMA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	1 / 51 (1.96%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	1	0	0	1	1	0	2	0	0	0	1	2	0	0
General disorders and administration site conditions
ASTHENIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	2 / 7 (28.57%)	1 / 6 (16.67%)	0 / 21 (0.00%)	2 / 62 (3.23%)	2 / 22 (9.09%)	14 / 304 (4.61%)	6 / 40 (15.00%)	5 / 24 (20.83%)	1 / 21 (4.76%)	3 / 51 (5.88%)	5 / 40 (12.50%)	26 / 201 (12.94%)	0 / 31 (0.00%)	2 / 20 (10.00%)	1 / 20 (5.00%)	4 / 47 (8.51%)	10 / 62 (16.13%)	1 / 21 (4.76%)	1 / 10 (10.00%)
occurrences all number	0	0	2	0	3	1	0	2	4	16	12	6	1	3	6	44	0	2	1	6	12	2	1
CHEST DISCOMFORT
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	3 / 201 (1.49%)	0 / 31 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	3	0	2	0	0	0	0	0
CHEST PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	1 / 24 (4.17%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	1 / 31 (3.23%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	1	0	1	0	0	0	0
CHILLS
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	2 / 21 (9.52%)	3 / 62 (4.84%)	2 / 22 (9.09%)	13 / 304 (4.28%)	3 / 40 (7.50%)	1 / 24 (4.17%)	4 / 21 (19.05%)	4 / 51 (7.84%)	0 / 40 (0.00%)	8 / 201 (3.98%)	6 / 31 (19.35%)	2 / 20 (10.00%)	1 / 20 (5.00%)	4 / 47 (8.51%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	1	0	0	0	1	2	4	2	13	3	1	4	4	0	10	7	2	1	4	3	0	0
EARLY SATIETY
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	1 / 22 (4.55%)	4 / 304 (1.32%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	1 / 31 (3.23%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	4	0	0	0	0	0	0	1	0	2	0	1	0	0
FACE OEDEMA
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 62 (3.23%)	1 / 22 (4.55%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	1	0	0	0	0	0	2	1	1	0	0	0	0	0	0	0	0	0	0	1	0	0
FATIGUE
subjects affected / exposed	1 / 4 (25.00%)	2 / 4 (50.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	3 / 7 (42.86%)	3 / 6 (50.00%)	8 / 21 (38.10%)	21 / 62 (33.87%)	11 / 22 (50.00%)	114 / 304 (37.50%)	20 / 40 (50.00%)	9 / 24 (37.50%)	10 / 21 (47.62%)	28 / 51 (54.90%)	7 / 40 (17.50%)	73 / 201 (36.32%)	19 / 31 (61.29%)	8 / 20 (40.00%)	9 / 20 (45.00%)	19 / 47 (40.43%)	15 / 62 (24.19%)	6 / 21 (28.57%)	4 / 10 (40.00%)
occurrences all number	1	3	0	1	5	7	13	29	13	165	23	12	10	73	11	91	24	8	11	23	19	7	4
GAIT DISTURBANCE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	2 / 201 (1.00%)	0 / 31 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	2	0	3	0	0	1	0	0
GENERAL PHYSICAL HEALTH DETERIORATION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	3 / 201 (1.49%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	3	0	0	0	1	4	0	0	0	1	0	0	0
GENERALISED OEDEMA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	0	1	0	0	0	1	0	0	1	0
HERNIA PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
INFLUENZA LIKE ILLNESS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	7 / 304 (2.30%)	2 / 40 (5.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	1 / 51 (1.96%)	2 / 40 (5.00%)	2 / 201 (1.00%)	1 / 31 (3.23%)	0 / 20 (0.00%)	1 / 20 (5.00%)	7 / 47 (14.89%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	7	2	0	3	1	2	2	1	0	1	8	0	1	0
MALAISE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	1 / 22 (4.55%)	2 / 304 (0.66%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	2 / 201 (1.00%)	1 / 31 (3.23%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	2	1	0	0	0	0	2	1	1	0	1	2	0	0
MUCOSAL INFLAMMATION
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	1 / 22 (4.55%)	4 / 304 (1.32%)	1 / 40 (2.50%)	1 / 24 (4.17%)	1 / 21 (4.76%)	2 / 51 (3.92%)	0 / 40 (0.00%)	6 / 201 (2.99%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	1	0	2	1	0	0	0	1	4	1	1	2	2	0	6	0	0	0	0	1	0	0
NON-CARDIAC CHEST PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 62 (1.61%)	0 / 22 (0.00%)	17 / 304 (5.59%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	2 / 201 (1.00%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	2 / 21 (9.52%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	1	1	0	18	1	0	0	0	1	2	1	0	0	4	0	4	0
OEDEMA PERIPHERAL
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	4 / 21 (19.05%)	5 / 62 (8.06%)	1 / 22 (4.55%)	31 / 304 (10.20%)	11 / 40 (27.50%)	2 / 24 (8.33%)	3 / 21 (14.29%)	5 / 51 (9.80%)	6 / 40 (15.00%)	28 / 201 (13.93%)	3 / 31 (9.68%)	1 / 20 (5.00%)	3 / 20 (15.00%)	9 / 47 (19.15%)	7 / 62 (11.29%)	2 / 21 (9.52%)	2 / 10 (20.00%)
occurrences all number	0	1	0	0	1	0	5	6	4	42	17	3	3	5	8	33	3	1	3	12	11	2	2
PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	1 / 22 (4.55%)	9 / 304 (2.96%)	1 / 40 (2.50%)	0 / 24 (0.00%)	1 / 21 (4.76%)	1 / 51 (1.96%)	0 / 40 (0.00%)	4 / 201 (1.99%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	3 / 47 (6.38%)	3 / 62 (4.84%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	11	1	0	1	1	0	4	0	0	0	3	3	0	0
PERIPHERAL SWELLING
subjects affected / exposed	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	1 / 22 (4.55%)	5 / 304 (1.64%)	2 / 40 (5.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	1	5	2	0	1	0	0	1	0	0	0	0	1	1	0
PYREXIA
subjects affected / exposed	0 / 4 (0.00%)	3 / 4 (75.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	2 / 7 (28.57%)	0 / 6 (0.00%)	1 / 21 (4.76%)	9 / 62 (14.52%)	4 / 22 (18.18%)	33 / 304 (10.86%)	6 / 40 (15.00%)	2 / 24 (8.33%)	4 / 21 (19.05%)	7 / 51 (13.73%)	6 / 40 (15.00%)	28 / 201 (13.93%)	4 / 31 (12.90%)	3 / 20 (15.00%)	5 / 20 (25.00%)	8 / 47 (17.02%)	11 / 62 (17.74%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	3	1	0	2	0	1	17	6	45	18	3	5	14	6	34	4	3	8	8	22	0	0
SWELLING FACE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	1 / 304 (0.33%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 47 (2.13%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	1	1	0	0	0	0	1	0	0	1	1	2	0	0
TEMPERATURE INTOLERANCE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	1	0	1	0	0	0	1	0
THIRST
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	1 / 40 (2.50%)	0 / 201 (0.00%)	2 / 31 (6.45%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	2	0	0	0	0	0	0
Immune system disorders
FOOD ALLERGY
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Reproductive system and breast disorders
BREAST PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	2 / 40 (5.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	2	0	0	0	0	0	1	0	0
BREAST TENDERNESS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	1	0	0	0	0
PELVIC PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	4 / 201 (1.99%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 47 (4.26%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	5	1	0	0	2	1	0	0
Respiratory, thoracic and mediastinal disorders
ATELECTASIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	2	0	0	1	0	1	0	0	0	0	0	0	0
COUGH
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	4 / 7 (57.14%)	1 / 6 (16.67%)	2 / 21 (9.52%)	9 / 62 (14.52%)	2 / 22 (9.09%)	77 / 304 (25.33%)	7 / 40 (17.50%)	5 / 24 (20.83%)	4 / 21 (19.05%)	12 / 51 (23.53%)	5 / 40 (12.50%)	24 / 201 (11.94%)	8 / 31 (25.81%)	2 / 20 (10.00%)	2 / 20 (10.00%)	1 / 47 (2.13%)	10 / 62 (16.13%)	6 / 21 (28.57%)	2 / 10 (20.00%)
occurrences all number	0	1	1	0	7	1	2	11	2	102	8	6	4	15	5	27	10	2	2	2	13	7	4
DYSPHONIA
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	2 / 21 (9.52%)	2 / 62 (3.23%)	2 / 22 (9.09%)	13 / 304 (4.28%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	1 / 40 (2.50%)	4 / 201 (1.99%)	2 / 31 (6.45%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	3 / 62 (4.84%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	1	0	0	0	0	2	2	2	15	0	0	0	2	1	4	2	0	1	0	3	1	0
DYSPNOEA
subjects affected / exposed	1 / 4 (25.00%)	1 / 4 (25.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	3 / 7 (42.86%)	1 / 6 (16.67%)	2 / 21 (9.52%)	15 / 62 (24.19%)	5 / 22 (22.73%)	75 / 304 (24.67%)	8 / 40 (20.00%)	6 / 24 (25.00%)	2 / 21 (9.52%)	17 / 51 (33.33%)	10 / 40 (25.00%)	27 / 201 (13.43%)	9 / 31 (29.03%)	1 / 20 (5.00%)	5 / 20 (25.00%)	9 / 47 (19.15%)	5 / 62 (8.06%)	3 / 21 (14.29%)	2 / 10 (20.00%)
occurrences all number	1	1	1	0	4	1	2	21	5	100	10	6	2	22	14	35	10	1	5	10	5	3	3
DYSPNOEA EXERTIONAL
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	2 / 62 (3.23%)	0 / 22 (0.00%)	8 / 304 (2.63%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	1 / 40 (2.50%)	4 / 201 (1.99%)	1 / 31 (3.23%)	0 / 20 (0.00%)	1 / 20 (5.00%)	3 / 47 (6.38%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	1	0	3	0	9	1	0	0	1	1	4	1	0	2	4	0	1	0
EPISTAXIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	8 / 304 (2.63%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	9	1	0	0	0	0	1	0	1	0	2	3	0	0
HAEMOPTYSIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	4 / 62 (6.45%)	0 / 22 (0.00%)	24 / 304 (7.89%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	8 / 201 (3.98%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	1	0	0	0	1	4	0	29	0	0	0	1	0	10	0	0	0	2	1	1	0
HICCUPS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	3 / 304 (0.99%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	2 / 51 (3.92%)	0 / 40 (0.00%)	3 / 201 (1.49%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	4	2	0	0	8	0	3	0	0	0	0	0	0	0
HYPOXIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	1 / 22 (4.55%)	8 / 304 (2.63%)	0 / 40 (0.00%)	1 / 24 (4.17%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	9	0	1	0	1	0	0	0	0	1	1	0	1	0
NASAL CONGESTION
subjects affected / exposed	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	3 / 62 (4.84%)	1 / 22 (4.55%)	10 / 304 (3.29%)	0 / 40 (0.00%)	3 / 24 (12.50%)	1 / 21 (4.76%)	4 / 51 (7.84%)	0 / 40 (0.00%)	4 / 201 (1.99%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	2 / 47 (4.26%)	4 / 62 (6.45%)	1 / 21 (4.76%)	1 / 10 (10.00%)
occurrences all number	1	0	0	2	0	0	0	3	1	13	0	4	1	4	0	4	0	0	1	2	9	2	1
OROPHARYNGEAL PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	7 / 62 (11.29%)	0 / 22 (0.00%)	17 / 304 (5.59%)	0 / 40 (0.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	2 / 51 (3.92%)	1 / 40 (2.50%)	9 / 201 (4.48%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 47 (4.26%)	3 / 62 (4.84%)	1 / 21 (4.76%)	2 / 10 (20.00%)
occurrences all number	0	0	0	1	0	0	0	8	0	20	0	0	1	2	1	9	0	0	0	2	3	1	2
PLEURAL EFFUSION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	5 / 62 (8.06%)	1 / 22 (4.55%)	14 / 304 (4.61%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	2 / 51 (3.92%)	1 / 40 (2.50%)	2 / 201 (1.00%)	2 / 31 (6.45%)	0 / 20 (0.00%)	2 / 20 (10.00%)	4 / 47 (8.51%)	1 / 62 (1.61%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	1	5	2	19	2	0	0	2	1	2	2	0	2	5	1	1	0
PLEURITIC PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	2 / 62 (3.23%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	2 / 201 (1.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	2 / 20 (10.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	1	2	0	0	0	0	0	0	0	2	0	0	2	0	0	0	0
PNEUMONITIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	3 / 62 (4.84%)	0 / 22 (0.00%)	6 / 304 (1.97%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	1 / 40 (2.50%)	1 / 201 (0.50%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	3	0	8	0	0	0	1	1	1	1	0	0	0	0	0	1
PNEUMOTHORAX
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 62 (3.23%)	0 / 22 (0.00%)	5 / 304 (1.64%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	0	2	0	5	0	0	0	0	1	1	0	0	0	0	0	0	0
PRODUCTIVE COUGH
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	2 / 62 (3.23%)	0 / 22 (0.00%)	20 / 304 (6.58%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	10 / 201 (4.98%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 47 (4.26%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	1	0	0	1	2	0	23	1	0	0	1	0	13	1	0	0	2	1	0	0
RESPIRATORY DISTRESS
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	1 / 22 (4.55%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (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	2	0
RHINITIS ALLERGIC
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	1	1	1	1	0	0
RHINORRHOEA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 7 (28.57%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	4 / 304 (1.32%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	3 / 201 (1.49%)	3 / 31 (9.68%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	1	2	0	0	0	0	5	0	0	0	1	0	4	3	0	0	1	1	0	0
SINUS CONGESTION
subjects affected / exposed	1 / 4 (25.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	3 / 304 (0.99%)	2 / 40 (5.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	0 / 51 (0.00%)	0 / 40 (0.00%)	2 / 201 (1.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	3	2	0	1	0	0	2	0	0	0	0	0	0	0
SNEEZING
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	1	1	0	1
UPPER-AIRWAY COUGH SYNDROME
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	8 / 304 (2.63%)	0 / 40 (0.00%)	0 / 24 (0.00%)	2 / 21 (9.52%)	0 / 51 (0.00%)	1 / 40 (2.50%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	8	0	0	2	0	1	0	0	0	0	1	1	0	0
WHEEZING
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 62 (3.23%)	1 / 22 (4.55%)	15 / 304 (4.93%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	3 / 201 (1.49%)	0 / 31 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	2 / 47 (4.26%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	1	0	0	1	0	0	2	1	17	0	0	0	0	0	4	0	1	1	2	0	0	0
Psychiatric disorders
AGITATION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	4 / 201 (1.99%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	5	0	1	0	0	0	0	0
ANXIETY
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	1 / 22 (4.55%)	16 / 304 (5.26%)	1 / 40 (2.50%)	1 / 24 (4.17%)	1 / 21 (4.76%)	2 / 51 (3.92%)	2 / 40 (5.00%)	7 / 201 (3.48%)	0 / 31 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	4 / 47 (8.51%)	8 / 62 (12.90%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	1	0	0	0	0	0	1	1	18	2	1	1	2	2	7	0	1	1	4	9	0	0
CONFUSIONAL STATE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	5 / 304 (1.64%)	2 / 40 (5.00%)	1 / 24 (4.17%)	1 / 21 (4.76%)	1 / 51 (1.96%)	0 / 40 (0.00%)	8 / 201 (3.98%)	4 / 31 (12.90%)	3 / 20 (15.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	1	0	0	0	0	1	0	5	2	1	1	1	0	10	4	3	0	0	0	0	0
DELIRIUM
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	3 / 304 (0.99%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	2 / 201 (1.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	3	0	0	0	1	0	2	0	1	0	0	0	0	0
DEPRESSION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	1 / 21 (4.76%)	3 / 62 (4.84%)	1 / 22 (4.55%)	10 / 304 (3.29%)	1 / 40 (2.50%)	1 / 24 (4.17%)	1 / 21 (4.76%)	3 / 51 (5.88%)	0 / 40 (0.00%)	8 / 201 (3.98%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	2 / 47 (4.26%)	2 / 62 (3.23%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	1	1	3	1	10	2	1	1	3	0	8	0	0	1	2	2	1	0
INSOMNIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	3 / 62 (4.84%)	2 / 22 (9.09%)	24 / 304 (7.89%)	7 / 40 (17.50%)	2 / 24 (8.33%)	1 / 21 (4.76%)	13 / 51 (25.49%)	2 / 40 (5.00%)	20 / 201 (9.95%)	1 / 31 (3.23%)	2 / 20 (10.00%)	0 / 20 (0.00%)	4 / 47 (8.51%)	7 / 62 (11.29%)	3 / 21 (14.29%)	0 / 10 (0.00%)
occurrences all number	0	0	1	0	0	0	1	4	3	26	7	6	4	25	2	22	1	2	0	4	10	3	0
IRRITABILITY
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	4 / 304 (1.32%)	0 / 40 (0.00%)	1 / 24 (4.17%)	0 / 21 (0.00%)	1 / 51 (1.96%)	1 / 40 (2.50%)	0 / 201 (0.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	4	0	1	0	1	1	0	0	1	0	1	0	0	0
LIBIDO DECREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
RESTLESSNESS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0
Product issues
DEVICE DISLOCATION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	1	0	0	1	0	0	0	0
Investigations
ACTIVATED PARTIAL THROMBOPLASTIN TIME PROLONGED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	1 / 22 (4.55%)	3 / 304 (0.99%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	1 / 40 (2.50%)	4 / 201 (1.99%)	2 / 31 (6.45%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	2	3	1	0	0	3	1	6	2	0	0	0	0	1	0
ALANINE AMINOTRANSFERASE INCREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 7 (14.29%)	0 / 6 (0.00%)	2 / 21 (9.52%)	3 / 62 (4.84%)	2 / 22 (9.09%)	19 / 304 (6.25%)	9 / 40 (22.50%)	1 / 24 (4.17%)	1 / 21 (4.76%)	1 / 51 (1.96%)	4 / 40 (10.00%)	17 / 201 (8.46%)	6 / 31 (19.35%)	1 / 20 (5.00%)	1 / 20 (5.00%)	7 / 47 (14.89%)	5 / 62 (8.06%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	1	1	0	2	3	3	25	20	1	2	1	4	21	14	1	2	8	9	0	0
ASPARTATE AMINOTRANSFERASE INCREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 7 (14.29%)	0 / 6 (0.00%)	2 / 21 (9.52%)	4 / 62 (6.45%)	3 / 22 (13.64%)	20 / 304 (6.58%)	20 / 40 (50.00%)	2 / 24 (8.33%)	2 / 21 (9.52%)	3 / 51 (5.88%)	7 / 40 (17.50%)	17 / 201 (8.46%)	5 / 31 (16.13%)	0 / 20 (0.00%)	1 / 20 (5.00%)	5 / 47 (10.64%)	5 / 62 (8.06%)	1 / 21 (4.76%)	2 / 10 (20.00%)
occurrences all number	0	0	0	1	1	0	2	4	3	26	30	2	3	5	12	21	13	0	1	6	11	1	4
BLOOD ALKALINE PHOSPHATASE INCREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	1 / 6 (16.67%)	1 / 21 (4.76%)	4 / 62 (6.45%)	1 / 22 (4.55%)	16 / 304 (5.26%)	9 / 40 (22.50%)	4 / 24 (16.67%)	0 / 21 (0.00%)	3 / 51 (5.88%)	4 / 40 (10.00%)	11 / 201 (5.47%)	5 / 31 (16.13%)	0 / 20 (0.00%)	3 / 20 (15.00%)	4 / 47 (8.51%)	4 / 62 (6.45%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	1	0	1	1	4	1	21	14	4	0	3	4	12	12	0	4	6	8	0	1
BLOOD BILIRUBIN INCREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	2 / 62 (3.23%)	2 / 22 (9.09%)	8 / 304 (2.63%)	6 / 40 (15.00%)	3 / 24 (12.50%)	1 / 21 (4.76%)	1 / 51 (1.96%)	1 / 40 (2.50%)	5 / 201 (2.49%)	2 / 31 (6.45%)	0 / 20 (0.00%)	1 / 20 (5.00%)	2 / 47 (4.26%)	2 / 62 (3.23%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	1	2	3	12	8	6	1	3	3	8	3	0	1	2	3	0	1
BLOOD CHOLESTEROL INCREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	3 / 304 (0.99%)	0 / 40 (0.00%)	0 / 24 (0.00%)	2 / 21 (9.52%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	3	0	0	5	0	0	0	0	0	0	0	1	0	0
BLOOD CREATININE INCREASED
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 62 (0.00%)	1 / 22 (4.55%)	12 / 304 (3.95%)	2 / 40 (5.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	2 / 51 (3.92%)	0 / 40 (0.00%)	21 / 201 (10.45%)	0 / 31 (0.00%)	0 / 20 (0.00%)	2 / 20 (10.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	2	21	2	0	1	4	0	27	0	0	2	1	2	0	0
BLOOD ELECTROLYTES DECREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
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
BLOOD FIBRINOGEN INCREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	4 / 304 (1.32%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	3 / 31 (9.68%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	4	0	0	0	0	0	1	3	0	0	0	0	0	0
BLOOD LACTATE DEHYDROGENASE INCREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	0 / 51 (0.00%)	2 / 40 (5.00%)	0 / 201 (0.00%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	1	0	0	1	0	2	0	1	0	0	1	0	0	0
BLOOD MAGNESIUM DECREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	2 / 201 (1.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	1	1	0	0	1
BLOOD THYROID STIMULATING HORMONE DECREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	1 / 40 (2.50%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	1	1	1	0	0	1	0	0	0	0
BLOOD THYROID STIMULATING HORMONE INCREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	8 / 304 (2.63%)	2 / 40 (5.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	0 / 51 (0.00%)	0 / 40 (0.00%)	2 / 201 (1.00%)	1 / 31 (3.23%)	0 / 20 (0.00%)	2 / 20 (10.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	10	2	0	1	0	0	2	1	0	2	0	0	0	1
CORTISOL DECREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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
GAMMA-GLUTAMYLTRANSFERASE INCREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	2 / 21 (9.52%)	5 / 62 (8.06%)	1 / 22 (4.55%)	12 / 304 (3.95%)	8 / 40 (20.00%)	3 / 24 (12.50%)	0 / 21 (0.00%)	3 / 51 (5.88%)	7 / 40 (17.50%)	11 / 201 (5.47%)	7 / 31 (22.58%)	0 / 20 (0.00%)	2 / 20 (10.00%)	4 / 47 (8.51%)	4 / 62 (6.45%)	3 / 21 (14.29%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	1	2	8	1	13	10	5	0	3	11	14	15	0	3	7	10	3	1
INTERNATIONAL NORMALISED RATIO INCREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	3 / 304 (0.99%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	4 / 201 (1.99%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	2 / 47 (4.26%)	1 / 62 (1.61%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	4	5	0	0	0	0	6	0	0	2	2	1	2	0
LYMPHOCYTE COUNT DECREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	2 / 201 (1.00%)	1 / 31 (3.23%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	2 / 62 (3.23%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	1	0	0	0	0	3	2	1	1	0	2	3	0
TRANSAMINASES INCREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	2 / 201 (1.00%)	2 / 31 (6.45%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	2	0	0	0	0	1	2	3	0	0	0	0	0	0
VITAMIN D DECREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
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
WEIGHT DECREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	2 / 21 (9.52%)	6 / 62 (9.68%)	2 / 22 (9.09%)	24 / 304 (7.89%)	2 / 40 (5.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	2 / 51 (3.92%)	0 / 40 (0.00%)	16 / 201 (7.96%)	6 / 31 (19.35%)	1 / 20 (5.00%)	1 / 20 (5.00%)	9 / 47 (19.15%)	4 / 62 (6.45%)	2 / 21 (9.52%)	2 / 10 (20.00%)
occurrences all number	0	0	0	0	0	1	2	6	3	30	2	0	2	2	0	19	8	1	3	13	7	2	2
WEIGHT INCREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	3 / 62 (4.84%)	0 / 22 (0.00%)	9 / 304 (2.96%)	2 / 40 (5.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	1 / 51 (1.96%)	1 / 40 (2.50%)	2 / 201 (1.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	3	0	14	2	0	2	1	1	3	0	1	0	0	1	0	1
WHITE BLOOD CELL COUNT DECREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	4 / 304 (1.32%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	6	0	0	0	0	0	1	0	1	0	0	1	2	0
WHITE BLOOD CELL COUNT INCREASED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	1 / 21 (4.76%)	0 / 62 (0.00%)	1 / 22 (4.55%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
CONTUSION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 62 (3.23%)	0 / 22 (0.00%)	3 / 304 (0.99%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	2 / 201 (1.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	3	0	0	0	0	0	2	0	1	0	1	0	0	0
FALL
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 62 (3.23%)	1 / 22 (4.55%)	7 / 304 (2.30%)	0 / 40 (0.00%)	2 / 24 (8.33%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	6 / 201 (2.99%)	0 / 31 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	3 / 47 (6.38%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	1	8	0	3	0	0	0	7	0	3	0	3	1	0	0
INFUSION RELATED REACTION
subjects affected / exposed	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 62 (0.00%)	0 / 22 (0.00%)	3 / 304 (0.99%)	0 / 40 (0.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	1 / 31 (3.23%)	0 / 20 (0.00%)	2 / 20 (10.00%)	2 / 47 (4.26%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	3	0	0	0	0	0	2	0	0	4	0	0	1	0	0	1	1	0	3	2	2	0	0
POST-TRAUMATIC PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	1 / 24 (4.17%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	2	0	0	0	0	0	1	0	1	0	0	0
PROCEDURAL PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	5 / 304 (1.64%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	2 / 201 (1.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	2 / 47 (4.26%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	5	0	0	0	0	0	2	0	1	0	2	1	0	0
SCAR
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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
SKIN ABRASION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	2 / 304 (0.66%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	3	1	0	0	0	0	0	0	1	0	0	1	1	0
SOFT TISSUE INJURY
subjects affected / exposed	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	1 / 24 (4.17%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
SPINAL COLUMN INJURY
subjects affected / exposed	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	1 / 22 (4.55%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	3	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Cardiac disorders
ATRIAL FIBRILLATION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	5 / 304 (1.64%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	2 / 201 (1.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	0	1	0	6	3	0	0	1	0	5	0	0	0	0	1	1	0
EXTRASYSTOLES
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
PALPITATIONS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	6 / 304 (1.97%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	4 / 201 (1.99%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	7	2	0	0	0	1	4	0	0	2	0	0	1	0
SINUS TACHYCARDIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	7 / 304 (2.30%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	2 / 47 (4.26%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	7	1	0	0	1	0	1	0	0	1	2	0	0	0
Nervous system disorders
AMNESIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0
APHASIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	3 / 20 (15.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	1	0	0	1	1	0	0	0	0	0	0	3	0	0	0	1	0
ATAXIA
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	1 / 40 (2.50%)	0 / 24 (0.00%)	1 / 21 (4.76%)	1 / 51 (1.96%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	2	1	0	1	1	0	1	0	2	0	0	0	0	0
BRAIN OEDEMA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	1	0	1	0	0	0	0	0
COGNITIVE DISORDER
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0
DIZZINESS
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	2 / 7 (28.57%)	0 / 6 (0.00%)	1 / 21 (4.76%)	5 / 62 (8.06%)	0 / 22 (0.00%)	23 / 304 (7.57%)	6 / 40 (15.00%)	2 / 24 (8.33%)	3 / 21 (14.29%)	9 / 51 (17.65%)	4 / 40 (10.00%)	11 / 201 (5.47%)	5 / 31 (16.13%)	2 / 20 (10.00%)	1 / 20 (5.00%)	5 / 47 (10.64%)	5 / 62 (8.06%)	3 / 21 (14.29%)	0 / 10 (0.00%)
occurrences all number	0	2	0	4	2	0	1	7	0	24	6	2	4	22	5	14	5	3	1	5	9	3	0
DIZZINESS POSTURAL
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	2 / 21 (9.52%)	1 / 62 (1.61%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	2	1	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0
DYSARTHRIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 62 (1.61%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	1 / 40 (2.50%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	2	0	1	1	0	0	0	0	0	1	2	0	0	0	0	0	0	0	0
DYSGEUSIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 62 (0.00%)	0 / 22 (0.00%)	5 / 304 (1.64%)	0 / 40 (0.00%)	1 / 24 (4.17%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	3 / 201 (1.49%)	2 / 31 (6.45%)	1 / 20 (5.00%)	0 / 20 (0.00%)	2 / 47 (4.26%)	1 / 62 (1.61%)	0 / 21 (0.00%)	3 / 10 (30.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	5	0	1	0	0	0	3	2	1	0	2	1	0	3
EXTRAPYRAMIDAL DISORDER
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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	0
HEADACHE
subjects affected / exposed	1 / 4 (25.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	8 / 62 (12.90%)	2 / 22 (9.09%)	33 / 304 (10.86%)	1 / 40 (2.50%)	4 / 24 (16.67%)	2 / 21 (9.52%)	5 / 51 (9.80%)	7 / 40 (17.50%)	10 / 201 (4.98%)	7 / 31 (22.58%)	9 / 20 (45.00%)	2 / 20 (10.00%)	6 / 47 (12.77%)	9 / 62 (14.52%)	4 / 21 (19.05%)	4 / 10 (40.00%)
occurrences all number	1	2	0	2	3	0	0	8	3	46	1	5	2	6	8	15	7	11	2	7	14	4	5
HEMIPARESIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	0 / 201 (0.00%)	0 / 31 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	1	0	0	0	1	0	0	2	0	0	0	0	0
HYPOAESTHESIA
subjects affected / exposed	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 62 (0.00%)	0 / 22 (0.00%)	3 / 304 (0.99%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	1 / 31 (3.23%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	0 / 21 (0.00%)	2 / 10 (20.00%)
occurrences all number	1	0	0	0	0	0	1	0	0	3	1	0	0	0	0	0	1	1	0	0	1	0	2
LETHARGY
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	3 / 304 (0.99%)	0 / 40 (0.00%)	0 / 24 (0.00%)	2 / 21 (9.52%)	2 / 51 (3.92%)	0 / 40 (0.00%)	2 / 201 (1.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	3	0	0	2	2	0	2	0	0	0	0	0	0	0
MEMORY IMPAIRMENT
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	3 / 304 (0.99%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	1	0	1	1	0	2	1	0
NERVOUS SYSTEM DISORDER
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0
NEUROPATHY PERIPHERAL
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	3 / 62 (4.84%)	0 / 22 (0.00%)	7 / 304 (2.30%)	1 / 40 (2.50%)	0 / 24 (0.00%)	1 / 21 (4.76%)	4 / 51 (7.84%)	2 / 40 (5.00%)	9 / 201 (4.48%)	2 / 31 (6.45%)	0 / 20 (0.00%)	2 / 20 (10.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	1	3	0	8	1	0	1	5	2	10	2	0	2	1	0	2	0
PARAESTHESIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	1 / 6 (16.67%)	1 / 21 (4.76%)	0 / 62 (0.00%)	1 / 22 (4.55%)	6 / 304 (1.97%)	0 / 40 (0.00%)	0 / 24 (0.00%)	2 / 21 (9.52%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	4 / 62 (6.45%)	0 / 21 (0.00%)	2 / 10 (20.00%)
occurrences all number	0	0	0	0	1	1	2	0	2	7	0	0	2	0	0	2	1	0	0	1	4	0	2
PAROSMIA
subjects affected / exposed	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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
PERIPHERAL MOTOR NEUROPATHY
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	2	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
PERIPHERAL SENSORY NEUROPATHY
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	0 / 40 (0.00%)	0 / 24 (0.00%)	2 / 21 (9.52%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	3 / 62 (4.84%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	2	0	0	1	0	0	0	0	3	0	0
SOMNOLENCE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	1 / 304 (0.33%)	3 / 40 (7.50%)	1 / 24 (4.17%)	0 / 21 (0.00%)	2 / 51 (3.92%)	0 / 40 (0.00%)	1 / 201 (0.50%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0	1	3	2	0	2	0	1	1	0	0	0	0	1	0
SYNCOPE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	4 / 62 (6.45%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	1 / 24 (4.17%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	2 / 201 (1.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	4	0	1	0	1	0	0	1	2	0	0	0	0	0	1	0
TASTE DISORDER
subjects affected / exposed	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	4 / 304 (1.32%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	2 / 51 (3.92%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	4	0	0	0	6	0	0	0	0	0	0	0	0	0
TREMOR
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	6 / 304 (1.97%)	1 / 40 (2.50%)	0 / 24 (0.00%)	1 / 21 (4.76%)	0 / 51 (0.00%)	0 / 40 (0.00%)	4 / 201 (1.99%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	7	1	0	1	0	0	4	0	0	0	0	0	0	0
VISUAL FIELD DEFECT
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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
Blood and lymphatic system disorders
ANAEMIA
subjects affected / exposed	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	10 / 62 (16.13%)	5 / 22 (22.73%)	47 / 304 (15.46%)	5 / 40 (12.50%)	1 / 24 (4.17%)	3 / 21 (14.29%)	7 / 51 (13.73%)	2 / 40 (5.00%)	43 / 201 (21.39%)	4 / 31 (12.90%)	2 / 20 (10.00%)	8 / 20 (40.00%)	10 / 47 (21.28%)	11 / 62 (17.74%)	5 / 21 (23.81%)	1 / 10 (10.00%)
occurrences all number	1	0	0	0	0	1	0	11	7	74	6	1	12	20	7	72	7	2	14	12	22	5	1
IRON DEFICIENCY ANAEMIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	4	0	0	0	0	0	0	0	0	1	0	0	0	0
LEUKOPENIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	3 / 304 (0.99%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	4	3	0	0	0	0	1	0	0	0	2	0	0	0
NEUTROPENIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	3 / 201 (1.49%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	8	3	0	0	0	1	5	0	1	0	0	0	0	0
SPLENOMEGALY
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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
THROMBOCYTOPENIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	8 / 304 (2.63%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	5 / 201 (2.49%)	1 / 31 (3.23%)	1 / 20 (5.00%)	1 / 20 (5.00%)	3 / 47 (6.38%)	0 / 62 (0.00%)	1 / 21 (4.76%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	12	7	0	0	0	0	9	1	1	2	4	0	2	1
Ear and labyrinth disorders
EAR PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 62 (3.23%)	1 / 22 (4.55%)	2 / 304 (0.66%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	2	1	3	1	0	0	1	0	0	0	0	1	0	0	0	1
EUSTACHIAN TUBE DYSFUNCTION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
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
HYPOACUSIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	1	0	0	1	0	1	0	0
OTORRHOEA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
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	1
TINNITUS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	0 / 40 (0.00%)	1 / 24 (4.17%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	1	0	2	0	1	0	1	0	0	1	0	0
Eye disorders
CATARACT
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	2 / 201 (1.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	2	0	1	0	0	0	0	1
CONJUNCTIVAL HYPERAEMIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
DIPLOPIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 62 (3.23%)	0 / 22 (0.00%)	2 / 304 (0.66%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	2	0	0	0	1	0	0	0	0	0	0	0	0	1
DRY EYE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	6 / 304 (1.97%)	1 / 40 (2.50%)	1 / 24 (4.17%)	1 / 21 (4.76%)	1 / 51 (1.96%)	1 / 40 (2.50%)	2 / 201 (1.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	6	1	1	1	1	1	3	0	1	0	0	2	0	0
EYE PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 62 (0.00%)	1 / 22 (4.55%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (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	1	0	0
REFRACTION DISORDER
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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	0
VISION BLURRED
subjects affected / exposed	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	3 / 62 (4.84%)	2 / 22 (9.09%)	7 / 304 (2.30%)	2 / 40 (5.00%)	1 / 24 (4.17%)	1 / 21 (4.76%)	2 / 51 (3.92%)	2 / 40 (5.00%)	2 / 201 (1.00%)	1 / 31 (3.23%)	0 / 20 (0.00%)	1 / 20 (5.00%)	2 / 47 (4.26%)	3 / 62 (4.84%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	1	0	0	0	0	0	1	3	2	7	2	1	1	4	2	2	1	0	1	2	4	1	0
VITREOUS FLOATERS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	2 / 201 (1.00%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	3 / 47 (6.38%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	2	1	0	0	3	0	1	0
ABDOMINAL DISTENSION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	2 / 21 (9.52%)	2 / 62 (3.23%)	1 / 22 (4.55%)	9 / 304 (2.96%)	5 / 40 (12.50%)	1 / 24 (4.17%)	0 / 21 (0.00%)	3 / 51 (5.88%)	0 / 40 (0.00%)	6 / 201 (2.99%)	1 / 31 (3.23%)	0 / 20 (0.00%)	1 / 20 (5.00%)	2 / 47 (4.26%)	3 / 62 (4.84%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	2	2	1	10	5	1	0	3	0	6	1	0	2	2	3	1	0
ABDOMINAL PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 7 (28.57%)	0 / 6 (0.00%)	3 / 21 (14.29%)	5 / 62 (8.06%)	4 / 22 (18.18%)	23 / 304 (7.57%)	11 / 40 (27.50%)	4 / 24 (16.67%)	1 / 21 (4.76%)	13 / 51 (25.49%)	2 / 40 (5.00%)	20 / 201 (9.95%)	9 / 31 (29.03%)	1 / 20 (5.00%)	3 / 20 (15.00%)	15 / 47 (31.91%)	12 / 62 (19.35%)	3 / 21 (14.29%)	3 / 10 (30.00%)
occurrences all number	0	0	0	1	3	0	3	6	5	28	12	4	2	27	4	25	12	1	5	23	24	3	3
ABDOMINAL PAIN LOWER
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	3 / 40 (7.50%)	1 / 24 (4.17%)	0 / 21 (0.00%)	1 / 51 (1.96%)	1 / 40 (2.50%)	3 / 201 (1.49%)	1 / 31 (3.23%)	0 / 20 (0.00%)	2 / 20 (10.00%)	0 / 47 (0.00%)	3 / 62 (4.84%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	3	1	0	1	1	3	1	0	3	0	3	0	0
ABDOMINAL PAIN UPPER
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 21 (4.76%)	2 / 62 (3.23%)	3 / 22 (13.64%)	7 / 304 (2.30%)	8 / 40 (20.00%)	4 / 24 (16.67%)	0 / 21 (0.00%)	4 / 51 (7.84%)	4 / 40 (10.00%)	5 / 201 (2.49%)	1 / 31 (3.23%)	3 / 20 (15.00%)	1 / 20 (5.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	1 / 21 (4.76%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	1	0	1	2	4	7	11	4	0	4	5	5	1	3	2	5	1	1	1
ANAL INCONTINENCE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	3 / 304 (0.99%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	3	0	1	0	0	0	0	0
ASCITES
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 62 (0.00%)	1 / 22 (4.55%)	2 / 304 (0.66%)	4 / 40 (10.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	5 / 51 (9.80%)	1 / 40 (2.50%)	2 / 201 (1.00%)	2 / 31 (6.45%)	0 / 20 (0.00%)	0 / 20 (0.00%)	7 / 47 (14.89%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	1	0	1	2	6	0	0	5	1	2	2	0	0	11	0	0	1
CONSTIPATION
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 7 (14.29%)	3 / 6 (50.00%)	2 / 21 (9.52%)	10 / 62 (16.13%)	6 / 22 (27.27%)	48 / 304 (15.79%)	11 / 40 (27.50%)	4 / 24 (16.67%)	4 / 21 (19.05%)	16 / 51 (31.37%)	5 / 40 (12.50%)	55 / 201 (27.36%)	9 / 31 (29.03%)	2 / 20 (10.00%)	3 / 20 (15.00%)	14 / 47 (29.79%)	13 / 62 (20.97%)	4 / 21 (19.05%)	0 / 10 (0.00%)
occurrences all number	0	1	0	2	1	3	2	11	7	55	12	4	4	20	5	63	10	2	3	16	18	4	0
DIARRHOEA
subjects affected / exposed	2 / 4 (50.00%)	2 / 4 (50.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	11 / 62 (17.74%)	6 / 22 (27.27%)	53 / 304 (17.43%)	10 / 40 (25.00%)	5 / 24 (20.83%)	5 / 21 (23.81%)	17 / 51 (33.33%)	5 / 40 (12.50%)	36 / 201 (17.91%)	4 / 31 (12.90%)	1 / 20 (5.00%)	1 / 20 (5.00%)	11 / 47 (23.40%)	18 / 62 (29.03%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	2	3	0	4	0	0	1	18	9	96	12	10	8	19	6	52	5	2	1	17	37	0	0
DRY MOUTH
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	4 / 62 (6.45%)	0 / 22 (0.00%)	17 / 304 (5.59%)	4 / 40 (10.00%)	1 / 24 (4.17%)	1 / 21 (4.76%)	5 / 51 (9.80%)	2 / 40 (5.00%)	11 / 201 (5.47%)	4 / 31 (12.90%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	5 / 62 (8.06%)	1 / 21 (4.76%)	2 / 10 (20.00%)
occurrences all number	0	0	0	0	0	0	1	4	0	19	4	1	2	7	2	14	4	0	0	1	5	1	2
DYSPEPSIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 62 (1.61%)	0 / 22 (0.00%)	10 / 304 (3.29%)	4 / 40 (10.00%)	2 / 24 (8.33%)	1 / 21 (4.76%)	3 / 51 (5.88%)	1 / 40 (2.50%)	12 / 201 (5.97%)	2 / 31 (6.45%)	1 / 20 (5.00%)	0 / 20 (0.00%)	5 / 47 (10.64%)	1 / 62 (1.61%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	1	1	0	11	4	2	1	3	1	12	2	1	0	5	1	1	0
DYSPHAGIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	5 / 62 (8.06%)	0 / 22 (0.00%)	15 / 304 (4.93%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	10 / 51 (19.61%)	2 / 40 (5.00%)	3 / 201 (1.49%)	0 / 31 (0.00%)	1 / 20 (5.00%)	1 / 20 (5.00%)	1 / 47 (2.13%)	3 / 62 (4.84%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	1	6	0	18	1	0	0	12	6	3	0	1	1	1	3	0	1
ERUCTATION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	3 / 51 (5.88%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	9	0	0	0	0	0	0	0	0	0
FAECALOMA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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	0
FLATULENCE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	3 / 304 (0.99%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	3 / 51 (5.88%)	1 / 40 (2.50%)	1 / 201 (0.50%)	4 / 31 (12.90%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 47 (4.26%)	1 / 62 (1.61%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	3	2	0	0	9	1	1	4	0	0	2	1	3	0
GASTROINTESTINAL PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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
GASTROOESOPHAGEAL REFLUX DISEASE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 62 (3.23%)	0 / 22 (0.00%)	11 / 304 (3.62%)	2 / 40 (5.00%)	1 / 24 (4.17%)	1 / 21 (4.76%)	7 / 51 (13.73%)	2 / 40 (5.00%)	4 / 201 (1.99%)	5 / 31 (16.13%)	0 / 20 (0.00%)	0 / 20 (0.00%)	3 / 47 (6.38%)	3 / 62 (4.84%)	3 / 21 (14.29%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	13	2	1	1	18	2	4	5	0	0	3	3	3	0
IMPAIRED GASTRIC EMPTYING
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0
LOOSE TOOTH
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
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
NAUSEA
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	3 / 7 (42.86%)	1 / 6 (16.67%)	2 / 21 (9.52%)	12 / 62 (19.35%)	7 / 22 (31.82%)	67 / 304 (22.04%)	14 / 40 (35.00%)	10 / 24 (41.67%)	5 / 21 (23.81%)	13 / 51 (25.49%)	9 / 40 (22.50%)	47 / 201 (23.38%)	10 / 31 (32.26%)	5 / 20 (25.00%)	2 / 20 (10.00%)	15 / 47 (31.91%)	18 / 62 (29.03%)	6 / 21 (28.57%)	3 / 10 (30.00%)
occurrences all number	0	2	0	6	3	1	2	15	8	82	16	14	8	26	9	70	15	6	2	25	30	6	3
ORAL PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	3 / 62 (4.84%)	0 / 22 (0.00%)	0 / 304 (0.00%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	3	0	0	1	0	0	0	0	0	0	0	0	1	0	0	1
STOMATITIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	4 / 304 (1.32%)	1 / 40 (2.50%)	0 / 24 (0.00%)	1 / 21 (4.76%)	2 / 51 (3.92%)	0 / 40 (0.00%)	7 / 201 (3.48%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	5	1	0	1	5	0	7	1	0	0	2	1	0	1
TOOTHACHE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 62 (0.00%)	0 / 22 (0.00%)	8 / 304 (2.63%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	2 / 201 (1.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	1	0	0	12	0	0	0	0	1	2	0	0	0	1	2	0	0
VOMITING
subjects affected / exposed	1 / 4 (25.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 7 (28.57%)	1 / 6 (16.67%)	1 / 21 (4.76%)	10 / 62 (16.13%)	6 / 22 (27.27%)	41 / 304 (13.49%)	10 / 40 (25.00%)	4 / 24 (16.67%)	5 / 21 (23.81%)	10 / 51 (19.61%)	7 / 40 (17.50%)	27 / 201 (13.43%)	8 / 31 (25.81%)	3 / 20 (15.00%)	2 / 20 (10.00%)	10 / 47 (21.28%)	8 / 62 (12.90%)	4 / 21 (19.05%)	3 / 10 (30.00%)
occurrences all number	1	2	0	0	3	1	1	13	10	53	16	4	5	35	8	39	16	4	3	15	15	5	3
Hepatobiliary disorders
CHOLESTASIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	2 / 40 (5.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	0	2	0	0	0	0	2	0	0	0
HEPATIC PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	1	0	0	0	2	0	0
HEPATOMEGALY
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	2 / 40 (5.00%)	1 / 24 (4.17%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	1	0	0	0	1	0	0	0	0	0	1	0
HYPERBILIRUBINAEMIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	1 / 304 (0.33%)	3 / 40 (7.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	1 / 40 (2.50%)	1 / 201 (0.50%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	1	6	0	0	1	1	1	5	0	0	2	0	0	0
JAUNDICE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	2	0	0	1	0	1	0	0	0	0	0	0	0
OCULAR ICTERUS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	3	0	0	1	0	0	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
ACNE
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	1	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
DERMATITIS ACNEIFORM
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
DERMATITIS PSORIASIFORM
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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	0
DRY SKIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	2 / 21 (9.52%)	3 / 62 (4.84%)	1 / 22 (4.55%)	14 / 304 (4.61%)	0 / 40 (0.00%)	2 / 24 (8.33%)	0 / 21 (0.00%)	2 / 51 (3.92%)	2 / 40 (5.00%)	7 / 201 (3.48%)	2 / 31 (6.45%)	0 / 20 (0.00%)	0 / 20 (0.00%)	3 / 47 (6.38%)	3 / 62 (4.84%)	1 / 21 (4.76%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	2	3	1	15	0	2	0	2	3	7	2	0	0	3	3	1	1
ECZEMA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	5 / 304 (1.64%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	1 / 40 (2.50%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	1 / 47 (2.13%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	5	0	0	0	1	1	0	0	0	1	1	3	0	0
ERYTHEMA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	6 / 62 (9.68%)	0 / 22 (0.00%)	6 / 304 (1.97%)	1 / 40 (2.50%)	1 / 24 (4.17%)	0 / 21 (0.00%)	1 / 51 (1.96%)	2 / 40 (5.00%)	3 / 201 (1.49%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	0	7	0	6	1	1	0	4	2	4	0	0	0	1	2	0	0
EXFOLIATIVE RASH
subjects affected / exposed	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
HYPERHIDROSIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	1 / 62 (1.61%)	1 / 22 (4.55%)	5 / 304 (1.64%)	0 / 40 (0.00%)	2 / 24 (8.33%)	0 / 21 (0.00%)	5 / 51 (9.80%)	1 / 40 (2.50%)	3 / 201 (1.49%)	2 / 31 (6.45%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	2	5	0	2	0	15	1	3	2	0	0	0	0	1	0
NIGHT SWEATS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	8 / 304 (2.63%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	7 / 201 (3.48%)	1 / 31 (3.23%)	0 / 20 (0.00%)	2 / 20 (10.00%)	1 / 47 (2.13%)	3 / 62 (4.84%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	8	0	0	0	0	0	9	1	0	2	1	3	0	0
PAIN OF SKIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0
PEMPHIGOID
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
PETECHIAE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	1 / 40 (2.50%)	0 / 24 (0.00%)	1 / 21 (4.76%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	1	0	1	0	0	1	0	0	0	0	0	0	0
PRURITUS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	3 / 21 (14.29%)	5 / 62 (8.06%)	2 / 22 (9.09%)	35 / 304 (11.51%)	16 / 40 (40.00%)	4 / 24 (16.67%)	5 / 21 (23.81%)	6 / 51 (11.76%)	5 / 40 (12.50%)	15 / 201 (7.46%)	5 / 31 (16.13%)	0 / 20 (0.00%)	3 / 20 (15.00%)	7 / 47 (14.89%)	10 / 62 (16.13%)	0 / 21 (0.00%)	2 / 10 (20.00%)
occurrences all number	0	0	0	4	0	0	4	5	3	49	20	4	7	8	6	20	8	0	3	10	12	0	3
PSORIASIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	3	0	0	3	0	1	0	0
RASH
subjects affected / exposed	0 / 4 (0.00%)	2 / 4 (50.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	1 / 7 (14.29%)	1 / 6 (16.67%)	1 / 21 (4.76%)	6 / 62 (9.68%)	2 / 22 (9.09%)	37 / 304 (12.17%)	5 / 40 (12.50%)	7 / 24 (29.17%)	4 / 21 (19.05%)	9 / 51 (17.65%)	1 / 40 (2.50%)	23 / 201 (11.44%)	4 / 31 (12.90%)	1 / 20 (5.00%)	1 / 20 (5.00%)	2 / 47 (4.26%)	3 / 62 (4.84%)	0 / 21 (0.00%)	2 / 10 (20.00%)
occurrences all number	0	4	0	3	1	1	1	6	2	54	7	12	7	13	1	28	6	1	1	2	3	0	2
RASH MACULO-PAPULAR
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	4 / 62 (6.45%)	1 / 22 (4.55%)	7 / 304 (2.30%)	1 / 40 (2.50%)	1 / 24 (4.17%)	1 / 21 (4.76%)	0 / 51 (0.00%)	0 / 40 (0.00%)	5 / 201 (2.49%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	5 / 62 (8.06%)	2 / 21 (9.52%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	1	6	1	13	1	1	2	0	0	13	1	0	0	1	5	2	0
VITILIGO
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	1 / 24 (4.17%)	2 / 21 (9.52%)	0 / 51 (0.00%)	0 / 40 (0.00%)	2 / 201 (1.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	1	0	1	2	0	0	2	0	0	0	0	0	0	0
Renal and urinary disorders
ACUTE KIDNEY INJURY
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 62 (0.00%)	0 / 22 (0.00%)	3 / 304 (0.99%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	8 / 201 (3.98%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 47 (4.26%)	5 / 62 (8.06%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	3	0	0	0	1	0	14	0	0	0	2	5	1	0
AUTOIMMUNE NEPHRITIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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
DYSURIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	2 / 304 (0.66%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	6 / 201 (2.99%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	2 / 62 (3.23%)	2 / 21 (9.52%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	2	1	0	0	0	1	6	0	0	0	1	2	2	1
HAEMATURIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	1 / 22 (4.55%)	1 / 304 (0.33%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	18 / 201 (8.96%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	3 / 47 (6.38%)	2 / 62 (3.23%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	2	1	2	0	0	0	0	28	0	0	0	3	4	1	0
NOCTURIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	1 / 40 (2.50%)	0 / 24 (0.00%)	1 / 21 (4.76%)	1 / 51 (1.96%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	1	1	0	1	0	0	0	0	0	0	1
POLLAKIURIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	3 / 201 (1.49%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	2	0	0	0	0	3	1	0	0	1	1	1	0
POLYURIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
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
PROTEINURIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	9 / 304 (2.96%)	2 / 40 (5.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	0 / 51 (0.00%)	0 / 40 (0.00%)	4 / 201 (1.99%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	3 / 47 (6.38%)	1 / 62 (1.61%)	2 / 21 (9.52%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	11	3	0	3	0	0	4	0	0	0	4	2	3	0
URINARY INCONTINENCE
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	1 / 22 (4.55%)	3 / 304 (0.99%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	5 / 201 (2.49%)	0 / 31 (0.00%)	2 / 20 (10.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	3	0	0	0	0	0	5	0	2	0	1	0	0	0
URINARY TRACT PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	2 / 22 (9.09%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	1	0	0	0	0	0	0	0
Endocrine disorders
HYPERTHYROIDISM
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 62 (0.00%)	2 / 22 (9.09%)	12 / 304 (3.95%)	2 / 40 (5.00%)	1 / 24 (4.17%)	0 / 21 (0.00%)	1 / 51 (1.96%)	1 / 40 (2.50%)	8 / 201 (3.98%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	2	19	2	1	0	1	1	10	0	0	0	1	1	0	0
HYPOTHYROIDISM
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 7 (14.29%)	0 / 6 (0.00%)	3 / 21 (14.29%)	5 / 62 (8.06%)	3 / 22 (13.64%)	29 / 304 (9.54%)	4 / 40 (10.00%)	1 / 24 (4.17%)	3 / 21 (14.29%)	2 / 51 (3.92%)	4 / 40 (10.00%)	17 / 201 (8.46%)	5 / 31 (16.13%)	2 / 20 (10.00%)	2 / 20 (10.00%)	4 / 47 (8.51%)	6 / 62 (9.68%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	1	0	1	1	0	3	5	3	34	4	1	4	2	5	21	6	2	3	4	6	0	1
Musculoskeletal and connective tissue disorders
ARTHRALGIA
subjects affected / exposed	1 / 4 (25.00%)	2 / 4 (50.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	2 / 21 (9.52%)	4 / 62 (6.45%)	3 / 22 (13.64%)	44 / 304 (14.47%)	6 / 40 (15.00%)	4 / 24 (16.67%)	9 / 21 (42.86%)	1 / 51 (1.96%)	4 / 40 (10.00%)	25 / 201 (12.44%)	3 / 31 (9.68%)	1 / 20 (5.00%)	5 / 20 (25.00%)	11 / 47 (23.40%)	9 / 62 (14.52%)	3 / 21 (14.29%)	2 / 10 (20.00%)
occurrences all number	1	3	0	0	0	0	3	9	3	62	6	5	14	2	5	40	3	2	6	15	14	3	2
BACK PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	1 / 6 (16.67%)	1 / 21 (4.76%)	7 / 62 (11.29%)	4 / 22 (18.18%)	49 / 304 (16.12%)	6 / 40 (15.00%)	2 / 24 (8.33%)	3 / 21 (14.29%)	13 / 51 (25.49%)	6 / 40 (15.00%)	30 / 201 (14.93%)	8 / 31 (25.81%)	2 / 20 (10.00%)	4 / 20 (20.00%)	8 / 47 (17.02%)	14 / 62 (22.58%)	4 / 21 (19.05%)	1 / 10 (10.00%)
occurrences all number	0	0	0	1	0	1	1	7	4	56	6	5	3	16	6	44	8	2	5	8	20	4	2
COCCYDYNIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	2 / 21 (9.52%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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
FLANK PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	2 / 62 (3.23%)	1 / 22 (4.55%)	2 / 304 (0.66%)	0 / 40 (0.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	2 / 51 (3.92%)	1 / 40 (2.50%)	9 / 201 (4.48%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	2 / 47 (4.26%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	1	2	1	2	0	0	1	2	1	9	0	0	1	2	0	0	0
FOOT DEFORMITY
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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
GROIN PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	3 / 62 (4.84%)	3 / 22 (13.64%)	1 / 304 (0.33%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	4 / 201 (1.99%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	3	6	1	1	0	0	1	0	4	0	0	0	0	1	0	1
JOINT SWELLING
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	3 / 47 (6.38%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	4	1	0	0
MUSCLE SPASMS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 62 (3.23%)	1 / 22 (4.55%)	10 / 304 (3.29%)	1 / 40 (2.50%)	4 / 24 (16.67%)	1 / 21 (4.76%)	1 / 51 (1.96%)	1 / 40 (2.50%)	7 / 201 (3.48%)	3 / 31 (9.68%)	0 / 20 (0.00%)	1 / 20 (5.00%)	2 / 47 (4.26%)	0 / 62 (0.00%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	1	0	0	0	2	1	10	1	4	1	1	1	10	3	0	1	2	0	1	0
MUSCLE TIGHTNESS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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	0
MUSCULAR WEAKNESS
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	2 / 21 (9.52%)	1 / 62 (1.61%)	0 / 22 (0.00%)	8 / 304 (2.63%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	2 / 201 (1.00%)	1 / 31 (3.23%)	2 / 20 (10.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	1	0	0	0	0	3	1	0	11	1	0	0	0	1	3	1	2	0	0	1	1	0
MUSCULOSKELETAL CHEST PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 21 (4.76%)	5 / 62 (8.06%)	1 / 22 (4.55%)	25 / 304 (8.22%)	4 / 40 (10.00%)	1 / 24 (4.17%)	3 / 21 (14.29%)	1 / 51 (1.96%)	6 / 40 (15.00%)	5 / 201 (2.49%)	1 / 31 (3.23%)	0 / 20 (0.00%)	4 / 20 (20.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	1	5	1	31	4	1	3	1	9	8	1	0	4	1	1	0	0
MUSCULOSKELETAL PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 7 (28.57%)	1 / 6 (16.67%)	3 / 21 (14.29%)	2 / 62 (3.23%)	1 / 22 (4.55%)	18 / 304 (5.92%)	6 / 40 (15.00%)	2 / 24 (8.33%)	2 / 21 (9.52%)	5 / 51 (9.80%)	2 / 40 (5.00%)	16 / 201 (7.96%)	2 / 31 (6.45%)	1 / 20 (5.00%)	3 / 20 (15.00%)	3 / 47 (6.38%)	3 / 62 (4.84%)	1 / 21 (4.76%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	3	1	3	2	2	23	8	2	2	33	3	23	2	1	3	4	4	1	1
MYALGIA
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 7 (14.29%)	0 / 6 (0.00%)	2 / 21 (9.52%)	7 / 62 (11.29%)	1 / 22 (4.55%)	31 / 304 (10.20%)	3 / 40 (7.50%)	5 / 24 (20.83%)	2 / 21 (9.52%)	3 / 51 (5.88%)	4 / 40 (10.00%)	14 / 201 (6.97%)	3 / 31 (9.68%)	1 / 20 (5.00%)	0 / 20 (0.00%)	4 / 47 (8.51%)	5 / 62 (8.06%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	1	0	1	1	0	3	8	1	41	5	7	2	3	5	23	4	1	0	5	6	0	0
NECK PAIN
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	7 / 62 (11.29%)	0 / 22 (0.00%)	7 / 304 (2.30%)	1 / 40 (2.50%)	0 / 24 (0.00%)	2 / 21 (9.52%)	2 / 51 (3.92%)	0 / 40 (0.00%)	3 / 201 (1.49%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	1	8	0	7	1	0	2	3	0	3	0	0	0	0	1	0	1
PAIN IN EXTREMITY
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	1 / 6 (16.67%)	2 / 21 (9.52%)	1 / 62 (1.61%)	1 / 22 (4.55%)	26 / 304 (8.55%)	3 / 40 (7.50%)	0 / 24 (0.00%)	3 / 21 (14.29%)	2 / 51 (3.92%)	2 / 40 (5.00%)	11 / 201 (5.47%)	0 / 31 (0.00%)	1 / 20 (5.00%)	4 / 20 (20.00%)	1 / 47 (2.13%)	3 / 62 (4.84%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	1	2	1	1	32	4	0	3	2	2	15	0	1	4	1	3	0	0
PAIN IN JAW
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	3 / 62 (4.84%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	4	0	1	0	0	0	0	1	0	0	0	0	0	0	0	1
SYNOVIAL CYST
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (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
Infections and infestations
ACUTE SINUSITIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0
BRONCHITIS
subjects affected / exposed	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	2 / 21 (9.52%)	2 / 62 (3.23%)	2 / 22 (9.09%)	11 / 304 (3.62%)	2 / 40 (5.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	1 / 51 (1.96%)	2 / 40 (5.00%)	3 / 201 (1.49%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	1	0	0	0	0	0	2	2	2	12	2	0	1	1	2	4	0	0	1	0	2	0	0
CANDIDA INFECTION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	2 / 304 (0.66%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	4 / 201 (1.99%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	2	1	0	0	0	0	4	0	0	0	1	1	0	1
ESCHERICHIA URINARY TRACT INFECTION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
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
EYE INFECTION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
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	1
FOLLICULITIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	2	0	0	0	0
GASTROENTERITIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	1 / 24 (4.17%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	0 / 21 (0.00%)	0 / 10 (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	1	0	0
GINGIVITIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	3 / 304 (0.99%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	3	2	0	0	0	0	0	0	0	0	0	0	0	0
HERPES ZOSTER
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	6 / 304 (1.97%)	0 / 40 (0.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	6	0	0	1	0	0	0	0	0	0	0	0	0	1
INFLUENZA
subjects affected / exposed	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	5 / 304 (1.64%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	1	0	0	0	1	0	0	0	0	5	1	0	0	1	0	0	0	0	0	0	0	0	0
NASOPHARYNGITIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	3 / 62 (4.84%)	0 / 22 (0.00%)	8 / 304 (2.63%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	1 / 40 (2.50%)	9 / 201 (4.48%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	4 / 62 (6.45%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	5	0	9	1	0	0	1	1	12	0	0	0	1	4	0	0
ONYCHOMYCOSIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	2 / 10 (20.00%)
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	2
ORAL CANDIDIASIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	1 / 62 (1.61%)	2 / 22 (9.09%)	13 / 304 (4.28%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	1 / 40 (2.50%)	4 / 201 (1.99%)	1 / 31 (3.23%)	1 / 20 (5.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	3 / 62 (4.84%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	1	0	3	2	15	0	0	0	1	1	4	1	1	1	0	3	0	1
OTITIS EXTERNA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
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	1
OTITIS MEDIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
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
PHARYNGITIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	5 / 304 (1.64%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	6	0	0	0	0	0	1	0	0	1	0	2	0	0
PNEUMONIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	3 / 62 (4.84%)	1 / 22 (4.55%)	25 / 304 (8.22%)	2 / 40 (5.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	1 / 51 (1.96%)	1 / 40 (2.50%)	5 / 201 (2.49%)	1 / 31 (3.23%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	2 / 21 (9.52%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	0	3	1	34	2	0	0	1	1	6	1	1	0	0	1	3	0
PYURIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	2 / 201 (1.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	2	0	0	0	0	0	0	0
RESPIRATORY TRACT INFECTION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	2	0	0	0
RHINITIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	2 / 22 (9.09%)	6 / 304 (1.97%)	1 / 40 (2.50%)	1 / 24 (4.17%)	0 / 21 (0.00%)	1 / 51 (1.96%)	0 / 40 (0.00%)	2 / 201 (1.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	3 / 62 (4.84%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	2	6	1	1	0	1	0	2	0	0	2	0	3	0	0
SINUSITIS
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	12 / 304 (3.95%)	2 / 40 (5.00%)	0 / 24 (0.00%)	1 / 21 (4.76%)	1 / 51 (1.96%)	0 / 40 (0.00%)	4 / 201 (1.99%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	2 / 62 (3.23%)	1 / 21 (4.76%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	14	3	0	1	1	0	6	0	0	0	0	2	1	1
SKIN INFECTION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	2	0	0
UPPER RESPIRATORY TRACT INFECTION
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	3 / 62 (4.84%)	0 / 22 (0.00%)	23 / 304 (7.57%)	1 / 40 (2.50%)	4 / 24 (16.67%)	2 / 21 (9.52%)	1 / 51 (1.96%)	0 / 40 (0.00%)	3 / 201 (1.49%)	1 / 31 (3.23%)	1 / 20 (5.00%)	1 / 20 (5.00%)	4 / 47 (8.51%)	8 / 62 (12.90%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	1	0	0	0	0	0	8	0	29	1	4	2	2	0	4	1	1	1	4	8	0	0
URINARY TRACT INFECTION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 21 (4.76%)	2 / 62 (3.23%)	5 / 22 (22.73%)	15 / 304 (4.93%)	4 / 40 (10.00%)	2 / 24 (8.33%)	0 / 21 (0.00%)	3 / 51 (5.88%)	2 / 40 (5.00%)	35 / 201 (17.41%)	3 / 31 (9.68%)	0 / 20 (0.00%)	4 / 20 (20.00%)	8 / 47 (17.02%)	10 / 62 (16.13%)	1 / 21 (4.76%)	1 / 10 (10.00%)
occurrences all number	0	0	0	5	1	0	1	2	8	17	6	2	0	3	2	55	3	0	7	8	14	2	2
VULVOVAGINAL MYCOTIC INFECTION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	1 / 62 (1.61%)	1 / 21 (4.76%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	1	0	2	1	1
Metabolism and nutrition disorders
DECREASED APPETITE
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 7 (14.29%)	2 / 6 (33.33%)	7 / 21 (33.33%)	7 / 62 (11.29%)	4 / 22 (18.18%)	80 / 304 (26.32%)	15 / 40 (37.50%)	5 / 24 (20.83%)	6 / 21 (28.57%)	22 / 51 (43.14%)	6 / 40 (15.00%)	51 / 201 (25.37%)	11 / 31 (35.48%)	4 / 20 (20.00%)	2 / 20 (10.00%)	14 / 47 (29.79%)	10 / 62 (16.13%)	4 / 21 (19.05%)	1 / 10 (10.00%)
occurrences all number	0	1	0	1	1	3	9	7	7	112	17	5	6	38	6	60	12	5	3	17	14	4	1
DEHYDRATION
subjects affected / exposed	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	3 / 21 (14.29%)	7 / 62 (11.29%)	2 / 22 (9.09%)	18 / 304 (5.92%)	0 / 40 (0.00%)	1 / 24 (4.17%)	4 / 21 (19.05%)	8 / 51 (15.69%)	2 / 40 (5.00%)	9 / 201 (4.48%)	5 / 31 (16.13%)	2 / 20 (10.00%)	1 / 20 (5.00%)	5 / 47 (10.64%)	4 / 62 (6.45%)	1 / 21 (4.76%)	2 / 10 (20.00%)
occurrences all number	0	1	1	0	0	1	3	8	2	24	0	1	4	11	2	12	6	2	1	5	4	1	3
FLUID INTAKE REDUCED
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
FLUID RETENTION
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 62 (3.23%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	2 / 40 (5.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	1	0	0	0	0	2	0	0	0	0	0	0	0	0
HYPERCALCAEMIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	1 / 6 (16.67%)	0 / 21 (0.00%)	7 / 62 (11.29%)	0 / 22 (0.00%)	16 / 304 (5.26%)	3 / 40 (7.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	10 / 201 (4.98%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	1	0	7	0	19	4	0	0	0	1	15	0	0	0	1	2	0	0
HYPERGLYCAEMIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 62 (3.23%)	1 / 22 (4.55%)	12 / 304 (3.95%)	4 / 40 (10.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	2 / 51 (3.92%)	0 / 40 (0.00%)	6 / 201 (2.99%)	2 / 31 (6.45%)	0 / 20 (0.00%)	0 / 20 (0.00%)	1 / 47 (2.13%)	1 / 62 (1.61%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	1	0	0	0	6	3	15	4	0	0	7	0	6	2	0	0	1	1	0	2
HYPERKALAEMIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	7 / 304 (2.30%)	1 / 40 (2.50%)	2 / 24 (8.33%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	15 / 201 (7.46%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	7	1	2	0	0	0	20	0	0	0	0	4	0	0
HYPERURICAEMIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	0 / 62 (0.00%)	0 / 22 (0.00%)	6 / 304 (1.97%)	3 / 40 (7.50%)	0 / 24 (0.00%)	1 / 21 (4.76%)	1 / 51 (1.96%)	0 / 40 (0.00%)	9 / 201 (4.48%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	2 / 62 (3.23%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	6	4	0	1	1	0	9	0	0	0	0	3	0	0
HYPOALBUMINAEMIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	3 / 62 (4.84%)	1 / 22 (4.55%)	20 / 304 (6.58%)	4 / 40 (10.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	3 / 40 (7.50%)	9 / 201 (4.48%)	2 / 31 (6.45%)	0 / 20 (0.00%)	0 / 20 (0.00%)	2 / 47 (4.26%)	3 / 62 (4.84%)	3 / 21 (14.29%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	4	1	22	4	0	0	0	4	10	2	0	0	2	3	3	0
HYPOCALCAEMIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	1 / 62 (1.61%)	0 / 22 (0.00%)	5 / 304 (1.64%)	1 / 40 (2.50%)	0 / 24 (0.00%)	0 / 21 (0.00%)	4 / 51 (7.84%)	1 / 40 (2.50%)	1 / 201 (0.50%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	3 / 62 (4.84%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	6	1	0	0	6	1	2	1	0	0	0	9	0	0
HYPOGLYCAEMIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	2 / 304 (0.66%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	1 / 40 (2.50%)	1 / 201 (0.50%)	1 / 31 (3.23%)	0 / 20 (0.00%)	0 / 20 (0.00%)	4 / 47 (8.51%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	0	1	1	1	0	0	5	0	0	2
HYPOKALAEMIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	2 / 62 (3.23%)	1 / 22 (4.55%)	22 / 304 (7.24%)	2 / 40 (5.00%)	0 / 24 (0.00%)	2 / 21 (9.52%)	1 / 51 (1.96%)	2 / 40 (5.00%)	11 / 201 (5.47%)	1 / 31 (3.23%)	3 / 20 (15.00%)	1 / 20 (5.00%)	4 / 47 (8.51%)	6 / 62 (9.68%)	1 / 21 (4.76%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	1	29	4	0	3	1	2	13	1	3	1	6	6	1	0
HYPOMAGNESAEMIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	1 / 21 (4.76%)	3 / 62 (4.84%)	1 / 22 (4.55%)	13 / 304 (4.28%)	3 / 40 (7.50%)	1 / 24 (4.17%)	2 / 21 (9.52%)	2 / 51 (3.92%)	1 / 40 (2.50%)	12 / 201 (5.97%)	2 / 31 (6.45%)	0 / 20 (0.00%)	0 / 20 (0.00%)	7 / 47 (14.89%)	4 / 62 (6.45%)	4 / 21 (19.05%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	0	0	1	4	1	17	6	1	4	2	1	15	3	0	0	8	8	5	0
HYPONATRAEMIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	1 / 21 (4.76%)	5 / 62 (8.06%)	1 / 22 (4.55%)	31 / 304 (10.20%)	5 / 40 (12.50%)	1 / 24 (4.17%)	0 / 21 (0.00%)	5 / 51 (9.80%)	3 / 40 (7.50%)	20 / 201 (9.95%)	3 / 31 (9.68%)	0 / 20 (0.00%)	1 / 20 (5.00%)	0 / 47 (0.00%)	4 / 62 (6.45%)	6 / 21 (28.57%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	1	6	1	49	8	3	0	5	5	25	3	0	1	0	4	7	0
IRON DEFICIENCY
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 7 (14.29%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	1 / 304 (0.33%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	1 / 201 (0.50%)	0 / 31 (0.00%)	0 / 20 (0.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	0 / 10 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0
POLYDIPSIA
subjects affected / exposed	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 7 (0.00%)	0 / 6 (0.00%)	0 / 21 (0.00%)	0 / 62 (0.00%)	0 / 22 (0.00%)	0 / 304 (0.00%)	0 / 40 (0.00%)	0 / 24 (0.00%)	0 / 21 (0.00%)	0 / 51 (0.00%)	0 / 40 (0.00%)	0 / 201 (0.00%)	0 / 31 (0.00%)	1 / 20 (5.00%)	0 / 20 (0.00%)	0 / 47 (0.00%)	0 / 62 (0.00%)	0 / 21 (0.00%)	1 / 10 (10.00%)
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

More information

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Were there any global substantial amendments to the protocol? Yes

11 Jul 2012

The first cohort was changed from sentinel participant cohort to a traditional 3 + 3 design. The first cohort was to enroll a minimum of 3 participants. The DLT evaluation period was changed to the time of first dose of durvalumab until the administration of the third dose. The DLT definition was modified to include any >= Grade 3 colitis and any >= Grade 3 immune-mediated adverse event (imAE) of rash, pruritus, or diarrhea that did not downgrade to <= Grade 2 within 3 days. The sample size was modified to reflect a total of up to approximately 110 evaluable participants and up to approximately 50 participants in the dose-escalation phase.

24 Jul 2012

The first immunogenicity assessment was scheduled during treatment on the day of the Dose 3 infusion.

12 Jun 2013

In dose-expansion phase, added tumor types of ACM, UM, HCC, SCCHN, NSCLC squamous and non-squamous histology, GEC, TNBC, and PAC and removed colorectal cancer. Changed duration of treatment from 6 months past observation of disease control plus an additional 6 months of maintenance (every 2 months) treatment to a treatment period of up to 12 months. Updated text to permit continuation of treatment in participants with confirmed PD but no signs of clinical deterioration if investigators considered that participant continued to receive benefit from treatment. Revised study objectives to support the changes to dose-expansion phase and addition of patient-reported outcome measures. Modified study-stopping criteria and withdrawal criteria. Changed antitumor activity assessment to RECIST v1.1 guidelines with modifications rather than immune-related response criteria. Removed Efficacy Evaluable Population and renamed Safety Population as As-treated Population.

04 Nov 2013

Increased the number of participants to be enrolled in the NSCLC cohorts. Modified inclusion criteria to define NSCLC requirements, to define the number of subjects, type of cancer and cohorts required to have PD-L1 tumor positivity, to further define disease progression, to describe requirements for NSCLC prior lines of therapy, to describe archival tumor sample requirements, to define RECIST v1.1 criteria, and to provide more details on tumor biopsy requirements.

21 May 2014

The protocol title was changed to indicate that it is a Phase 1/2 study. Increased the number of participants in the SCCHN, pancreatic adenocarcinoma, and uveal melanoma expansion cohorts. Added new expansion cohorts, a primary efficacy objective, and an exploratory efficacy objective. Updated inclusion criteria. Added pneumonitis as a potential imAE.

18 Jun 2014

The expanded second-line SCCHN cohort was removed.

17 Nov 2014

Tumoral PD-L1 requirements were changed. Criterion for untreated central nervous system metastases was clarified.

25 Nov 2015

The UC cohort in the dose-expansion phase was expanded.

04 Feb 2016

Eligibility criteria for the UC cohort were updated. PD-L1 testing requirements for the UC cohort were updated.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

1022 participants were enrolled, not N=1024 indicated in participant flow. Discrepancy is due to duplicate reporting of 2 NSCLC participants once in 10mg/kg dose-escalation cohort (N=6) and again in N=302 NSCLC 10mg/kg dose expansion cohort (N=304).

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Clinical trials

Clinical Trial Results: A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase

Primary: Number of Participants With Dose-limiting Toxicities in the Dose-escalation Phase

Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

Primary: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

Primary: Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion phase

Primary: Number of Participants With Abnormal Clinical Laboratory Parameters Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion phase

Primary: Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

Primary: Number of Participants With Abnormal Vital Signs Reported as TEAEs in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

Primary: Number of Participants With Change From Baseline in QT/QTc Interval in Local Electrocardiogram in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

Primary: Number of Participants With Change From Baseline in QT/QTc Interval in Local Electrocardiogram in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

Primary: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) in Participants With Non-squamous NSCLC who had Received 2 or More Prior Lines of Therapy in the Dose-expansion Phase

Primary: Objective Response Rate (ORR) Assessed by Blinded Independent Central Review (BICR) in Participants With Non-squamous NSCLC who had Received 2 or More Prior Lines of Therapy in the Dose-expansion Phase

Primary: ORR Assessed by BICR in Participants With Squamous NSCLC who had Received 1 and 2 or More Prior Lines of Therapy in the Dose-expansion Phase

Primary: ORR Assessed by BICR in Participants With Squamous NSCLC who had Received 1 and 2 or More Prior Lines of Therapy in the Dose-expansion Phase

Primary: ORR Assessed by BICR in Participants With UC Post-platinum (Programmed Cell Death Ligand [PD-L1] Status High) who had Received at Least 1 Line of Prior Therapy (2L+) in the Dose-expansion Phase

Primary: ORR Assessed by BICR in Participants With UC Post-platinum (Programmed Cell Death Ligand [PD-L1] Status High) who had Received at Least 1 Line of Prior Therapy (2L+) in the Dose-expansion Phase

Secondary: Area Under the Serum Concentration-time Curve up to the Last Measurable Concentration (AUClast) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase

Secondary: Area Under the Serum Concentration-time Curve up to the Last Measurable Concentration (AUClast) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase

Secondary: Maximum Serum Concentration (Cmax) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase

Secondary: Maximum Serum Concentration (Cmax) of MEDI4736 After the First Dose in the Dose-escalation and Dose-exploration Phase

Secondary: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI4736 in the Dose-escalation, Dose-exploration Phase, and Dose-expansion Phase.

Secondary: Number of Participants With Positive Anti-drug Antibodies (ADA) to MEDI4736 in the Dose-escalation, Dose-exploration Phase, and Dose-expansion Phase.

Secondary: Number of Participants With Best Overall Response (BOR) Assessed by BICR in NSCLC and SCCHN cohort in the Dose-expansion Phase

Secondary: Number of Participants With Best Overall Response (BOR) Assessed by BICR in NSCLC and SCCHN cohort in the Dose-expansion Phase

Secondary: Number of Participants With BOR Assessed by Investigator in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

Secondary: Number of Participants With BOR Assessed by Investigator in the Dose-escalation, Dose-exploration, and Dose-expansion Phase

Secondary: Duration of Response (DoR) Assessed by BICR in NSCLC and SCCHN cohort in the Dose-expansion Phase

Secondary: Duration of Response (DoR) Assessed by BICR in NSCLC and SCCHN cohort in the Dose-expansion Phase

Secondary: DoR assessed by Investigator in the Dose-expansion Phase

Secondary: DoR assessed by Investigator in the Dose-expansion Phase

Secondary: Disease Control Rate (DCR) Assessed by BICR in NSCLC and SCCHN cohort in the Dose-expansion Phase

Secondary: Disease Control Rate (DCR) Assessed by BICR in NSCLC and SCCHN cohort in the Dose-expansion Phase

Secondary: DCR Assessed by Investigator in the Dose-expansion Phase

Secondary: DCR Assessed by Investigator in the Dose-expansion Phase

Secondary: Progression-free Survival (PFS) Assessed by BICR in NSCLC cohort in the Dose-expansion Phase

Secondary: Progression-free Survival (PFS) Assessed by BICR in NSCLC cohort in the Dose-expansion Phase

Secondary: PFS Assessed by BICR in SCCHN cohort in the Dose-expansion Phase

Secondary: PFS Assessed by BICR in SCCHN cohort in the Dose-expansion Phase

Secondary: PFS Assessed by Investigator in the Dose-expansion Phase

Secondary: PFS Assessed by Investigator in the Dose-expansion Phase

Secondary: Overall Survival (OS) in the Dose-Expansion Phase

Secondary: Overall Survival (OS) in the Dose-Expansion Phase

Secondary: ORR Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: ORR Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: ORR Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: ORR Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: DoR Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: DoR Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: DoR Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: DoR Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: DCR Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: DCR Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: DCR Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: DCR Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: PFS Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: PFS Assessed by BICR in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: PFS Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: PFS Assessed by Investigator in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: OS in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: OS in UC Cohort (PD-L1 low/Negative, Total, and PD-L1 high) in the Dose-expansion Phase

Secondary: Adjusted Comparison of PFS by PD-L1 status in UC Cohort in the Dose-expansion Phase

Secondary: Adjusted Comparison of PFS by PD-L1 status in UC Cohort in the Dose-expansion Phase

Secondary: Adjusted Comparison of OS by PD-L1 status in UC Cohort in the Dose-expansion Phase

Secondary: Adjusted Comparison of OS by PD-L1 status in UC Cohort in the Dose-expansion Phase

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Clinical Trial Results:
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors