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Clinical Trial Results:
A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors

Summary
EudraCT number	2018-000416-21
Trial protocol	ES DE PL FI IT RO
Global end of trial date	07 Nov 2024

Results information
Results version number	v1(current)
This version publication date	22 Nov 2025
First version publication date	22 Nov 2025
Other versions

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

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Trial information

Top of page

Sponsor protocol code

CA030-001

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Bristol-Myers Squibb

Sponsor organisation address

Chaussée de la Hulpe 185, Brussels, Belgium, 1170

Public contact

Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, mg-gsm-ct@bms.com

Scientific contact

Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, mg-gsm-ct@bms.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

07 Nov 2024

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

07 Nov 2024

Was the trial ended prematurely?

Main objective of the trial

To characterize the safety, tolerability, and DLTs and to determine the MTD/RP2D of BMS-986249 administered as monotherapy and in combination with nivolumab in participants with advanced solid tumors (Parts 1A and 1B) To evaluate the preliminary safety and tolerability of BMS-986249 in combination with nivolumab (Arm C and Arm F) relative to ipilimumab in combination with nivolumab (Arm D) in participants with previously untreated, unresectable or metastatic melanoma To evaluate the preliminary efficacy of BMS- 986249 in combination with nivolumab (Arm C and Arm F) relative to historic nivolumab monotherapy data in participants with previously untreated, unresectable or metastatic melanoma

Protection of trial subjects

The study was in compliance with the ethical principles derived from the Declaration of Helsinki and in compliance with all International Conference on Harmonization Good Clinical Practice Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

06 Dec 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Finland: 4

Country: Number of subjects enrolled

Germany: 30

Country: Number of subjects enrolled

Italy: 24

Country: Number of subjects enrolled

Poland: 2

Country: Number of subjects enrolled

Spain: 41

Country: Number of subjects enrolled

Canada: 2

Country: Number of subjects enrolled

United States: 90

Country: Number of subjects enrolled

Argentina: 35

Country: Number of subjects enrolled

Australia: 13

Country: Number of subjects enrolled

Chile: 97

Country: Number of subjects enrolled

Romania: 18

Worldwide total number of subjects

356

EEA total number of subjects

119

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)

221

From 65 to 84 years

135

85 years and over

Subject disposition

Top of page

Recruitment details

Screening details

356 subjects enrolled and treated

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

Part 1A: BMS-986249 240 mg Monotherapy

Arm description

BMS-986249 240 mg IV every 4 weeks (Q4W), up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Part 1A: BMS-986249 800 mg Monotherapy

Arm description

BMS-986249 800 mg IV every 4 weeks (Q4W), up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Part 1A: BMS-986249 1600 mg Monotherapy

Arm description

BMS-986249 1600 mg IV every 4 weeks (Q4W), up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Part 1A: BMS-986249 2400 mg Monotherapy

Arm description

BMS-986249 2400 mg IV every 4 weeks (Q4W), up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Part 1A: BMS-986249 1600 mg Q8W Monotherapy

Arm description

BMS-986249 1600 mg IV every 8 weeks (Q8W), up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Part 1B: BMS-986249 240 mg Q4W + Nivo Combination

Arm description

BMS-986249 240 mg IV every 4 weeks (Q4W) + nivolumab 480 mg IV Q4W, up to 2 years

Arm type

Experimental

Investigational medicinal product name

nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

100mg/vial (10mg/mL)

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination

Arm description

BMS-986249 800 mg IV every 4 weeks (Q4W) + nivolumab 480 mg IV Q4W, up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Investigational medicinal product name

nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

100mg/vial (10mg/mL)

Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination

Arm description

BMS-986249 1200 mg IV every 4 weeks (Q4W) + nivolumab 480 mg IV Q4W, up to 2 years

Arm type

Experimental

Investigational medicinal product name

nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

100mg/vial (10mg/mL)

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination

Arm description

BMS-986249 800 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Investigational medicinal product name

nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

100mg/vial (10mg/mL)

Part 1B: BMS-986249 1200 mg Q8W+ Nivo Combination

Arm description

BMS-986249 1200 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Arm type

Experimental

Investigational medicinal product name

nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

100mg/vial (10mg/mL)

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination

Arm description

BMS-986249 1600 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Arm type

Experimental

Investigational medicinal product name

nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

100mg/vial (10mg/mL)

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Part 2A Arm A: BMS-986249 240 mg Q3W + Nivo 360 mg Q3W

Arm description

BMS-986249 240 mg IV every 3 weeks (Q3W) + nivolumab 360 mg IV every 3 weeks (Q3W) (4 doses), then nivolumab 480 mg IV every 4 weeks (Q4W) (maintenance), up to 2 years.

Arm type

Experimental

Investigational medicinal product name

nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

100mg/vial (10mg/mL)

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Part 2A Arm B: BMS-986249 800 mg + Nivo 480 mg Q4W

Arm description

BMS-986249 800 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Arm type

Experimental

Investigational medicinal product name

nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

100mg/vial (10mg/mL)

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W

Arm description

BMS-986249 1200 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Arm type

Experimental

Investigational medicinal product name

nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

100mg/vial (10mg/mL)

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Part 2A Arm D: ipilimumab 3 mg/kg Q3W + Nivo 1 mg/kg Q3W

Arm description

Ipilimumab 3 mg/kg IV every 3 weeks (Q3W) + nivolumab 1 mg/kg IV Q3W (4 doses), then nivolumab 480 mg IV every 4 weeks (Q4W) monotherapy, up to 2 years.

Arm type

Experimental

Investigational medicinal product name

ipilimumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

50mg/vial (5mg/mL)

Investigational medicinal product name

nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

100mg/vial (10mg/mL)

Part 2A Arm E: Nivo 480 mg Q4W Monotherapy

Arm description

Nivolumab 480 mg IV every 4 weeks (Q4W) monotherapy, up to 2 years.

Arm type

Experimental

Investigational medicinal product name

nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

100mg/vial (10mg/mL)

Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W

Arm description

BMS-986249 600 mg IV every 4 weeks (Q4W) + nivolumab 480 mg IV Q4W, up to 2 years.

Arm type

Experimental

Investigational medicinal product name

nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

100mg/vial (10mg/mL)

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Part 2B: Cohort 1 (Advanced or Intermediate HCC)

Arm description

BMS-986249 1200 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Arm type

Experimental

Investigational medicinal product name

nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

100mg/vial (10mg/mL)

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Part 2B: Cohort 2 (Metastatic CRPC)

Arm description

BMS-986249 1200 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years.

Arm type

Experimental

Investigational medicinal product name

nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

100mg/vial (10mg/mL)

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Part 2B: Cohort 3 (Unresectable TNBC)

Arm description

BMS-986249 1200 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years.

Arm type

Experimental

Investigational medicinal product name

nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

100mg/vial (10mg/mL)

Investigational medicinal product name

BMS-986249

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Subcutaneous use

Dosage and administration details

160mg/vial (40mg/mL)

Number of subjects in period 1	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivo Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivo Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A Arm A: BMS-986249 240 mg Q3W + Nivo 360 mg Q3W	Part 2A Arm B: BMS-986249 800 mg + Nivo 480 mg Q4W	Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W	Part 2A Arm D: ipilimumab 3 mg/kg Q3W + Nivo 1 mg/kg Q3W	Part 2A Arm E: Nivo 480 mg Q4W Monotherapy	Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC)	Part 2B: Cohort 2 (Metastatic CRPC)	Part 2B: Cohort 3 (Unresectable TNBC)
Started	6	11	10	1	11	12	11	9	13	9	10	3	3	58	59	3	36	5	41	45
Treated	6	11	10	1	11	12	11	9	13	9	10	3	3	57	58	3	36	5	41	45
Completed	0	0	0	0	0	0	0	0	0	1	0	0	0	6	7	1	2	0	1	3
Not completed	6	11	10	1	11	12	11	9	13	8	10	3	3	52	52	2	34	5	40	42
Adverse event, serious fatal	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-	-	-	-	1	-
Disease progression	6	8	5	1	9	9	4	6	10	7	4	1	1	25	22	2	10	1	18	28
Participant withdrew consent	-	1	1	-	-	-	1	1	1	-	-	1	-	-	3	-	1	-	4	2
Study drug toxicity	-	1	4	-	1	2	4	2	2	-	6	1	2	19	19	-	18	3	11	7
Randomized but not treated	-	-	-	-	-	-	-	-	-	-	-	-	-	1	1	-	-	-	-	-
Participant no longer meets study criteria	-	-	-	-	-	-	-	-	-	-	-	-	-	-	2	-	2	-	-	-
Adverse event unrelated to study drug	-	-	-	-	-	-	1	-	-	1	-	-	-	4	2	-	2	1	3	2
Other reasons	-	-	-	-	-	-	-	-	-	-	-	-	-	1	2	-	1	-	-	2
Lost to follow-up	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	2	1
Participant request to discontinue study treatment	-	1	-	-	1	1	1	-	-	-	-	-	-	1	1	-	-	-	1	-

Baseline characteristics

Top of page

Reporting group title

Part 1A: BMS-986249 240 mg Monotherapy

Reporting group description

BMS-986249 240 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 1A: BMS-986249 800 mg Monotherapy

Reporting group description

BMS-986249 800 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 1A: BMS-986249 1600 mg Monotherapy

Reporting group description

BMS-986249 1600 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 1A: BMS-986249 2400 mg Monotherapy

Reporting group description

BMS-986249 2400 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 1A: BMS-986249 1600 mg Q8W Monotherapy

Reporting group description

BMS-986249 1600 mg IV every 8 weeks (Q8W), up to 2 years

Reporting group title

Part 1B: BMS-986249 240 mg Q4W + Nivo Combination

Reporting group description

BMS-986249 240 mg IV every 4 weeks (Q4W) + nivolumab 480 mg IV Q4W, up to 2 years

Reporting group title

Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination

Reporting group description

BMS-986249 800 mg IV every 4 weeks (Q4W) + nivolumab 480 mg IV Q4W, up to 2 years

Reporting group title

Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination

Reporting group description

BMS-986249 1200 mg IV every 4 weeks (Q4W) + nivolumab 480 mg IV Q4W, up to 2 years

Reporting group title

Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination

Reporting group description

BMS-986249 800 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 1B: BMS-986249 1200 mg Q8W+ Nivo Combination

Reporting group description

BMS-986249 1200 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination

Reporting group description

BMS-986249 1600 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 2A Arm A: BMS-986249 240 mg Q3W + Nivo 360 mg Q3W

Reporting group description

BMS-986249 240 mg IV every 3 weeks (Q3W) + nivolumab 360 mg IV every 3 weeks (Q3W) (4 doses), then nivolumab 480 mg IV every 4 weeks (Q4W) (maintenance), up to 2 years.

Reporting group title

Part 2A Arm B: BMS-986249 800 mg + Nivo 480 mg Q4W

Reporting group description

BMS-986249 800 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W

Reporting group description

BMS-986249 1200 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 2A Arm D: ipilimumab 3 mg/kg Q3W + Nivo 1 mg/kg Q3W

Reporting group description

Ipilimumab 3 mg/kg IV every 3 weeks (Q3W) + nivolumab 1 mg/kg IV Q3W (4 doses), then nivolumab 480 mg IV every 4 weeks (Q4W) monotherapy, up to 2 years.

Reporting group title

Part 2A Arm E: Nivo 480 mg Q4W Monotherapy

Reporting group description

Nivolumab 480 mg IV every 4 weeks (Q4W) monotherapy, up to 2 years.

Reporting group title

Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W

Reporting group description

BMS-986249 600 mg IV every 4 weeks (Q4W) + nivolumab 480 mg IV Q4W, up to 2 years.

Reporting group title

Part 2B: Cohort 1 (Advanced or Intermediate HCC)

Reporting group description

BMS-986249 1200 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 2B: Cohort 2 (Metastatic CRPC)

Reporting group description

BMS-986249 1200 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years.

Reporting group title

Part 2B: Cohort 3 (Unresectable TNBC)

Reporting group description

BMS-986249 1200 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years.

Reporting group values	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivo Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivo Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A Arm A: BMS-986249 240 mg Q3W + Nivo 360 mg Q3W	Part 2A Arm B: BMS-986249 800 mg + Nivo 480 mg Q4W	Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W	Part 2A Arm D: ipilimumab 3 mg/kg Q3W + Nivo 1 mg/kg Q3W	Part 2A Arm E: Nivo 480 mg Q4W Monotherapy	Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC)	Part 2B: Cohort 2 (Metastatic CRPC)	Part 2B: Cohort 3 (Unresectable TNBC)	Total
Number of subjects	6	11	10	1	11	12	11	9	13	9	10	3	3	58	59	3	36	5	41	45	356
Age categorical
Units: Subjects
Adults (18-64 years)	4	6	5	1	6	10	10	5	11	7	6	1	0	34	39	1	22	3	12	38	221
From 65-84 years	2	5	5	0	5	2	1	4	2	2	4	2	3	24	20	2	14	2	29	7	135
Age Continuous
Here "99999" = NA
Units: years
arithmetic mean (standard deviation)	54.0 ( 18.9 )	64.8 ( 7.5 )	60.4 ( 10.2 )	64 ( 99999 )	60.3 ( 11.6 )	56.3 ( 8.8 )	53.9 ( 12.4 )	61.4 ( 11.2 )	55.3 ( 11.4 )	59.0 ( 8.0 )	60.1 ( 9.9 )	60.7 ( 13.6 )	73.3 ( 7.6 )	61.4 ( 14.7 )	57.3 ( 13.8 )	59.7 ( 24.8 )	60.3 ( 12.4 )	60.4 ( 9.8 )	68.6 ( 8.0 )	51.2 ( 12.8 )	-
Sex: Female, Male
Units: Participants
Female	3	8	8	0	7	9	4	1	4	5	4	1	1	22	27	1	19	1	0	45	170
Male	3	3	2	1	4	3	7	8	9	4	6	2	2	36	32	2	17	4	41	0	186
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Asian	0	0	1	0	0	0	0	0	2	0	0	0	0	0	2	0	0	0	0	0	5
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Black or African American	1	0	1	0	2	0	0	1	2	0	0	0	0	1	0	0	0	0	0	1	9
White	4	11	7	1	8	11	11	6	9	9	10	3	3	57	57	3	36	5	40	44	335
More than one race	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	1	0	1	0	1	1	0	2	0	0	0	0	0	0	0	0	0	0	1	0	7
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	1	1	0	1	2	2	1	0	1	0	2	0	1	7	11	0	2	1	3	3	39
Not Hispanic or Latino	5	10	8	0	7	10	10	6	10	8	6	3	1	11	8	1	11	1	6	13	135
Unknown or Not Reported	0	0	2	0	2	0	0	3	2	1	2	0	1	40	40	2	23	3	32	29	182

End points

Top of page

Reporting group title

Part 1A: BMS-986249 240 mg Monotherapy

Reporting group description

BMS-986249 240 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 1A: BMS-986249 800 mg Monotherapy

Reporting group description

BMS-986249 800 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 1A: BMS-986249 1600 mg Monotherapy

Reporting group description

BMS-986249 1600 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 1A: BMS-986249 2400 mg Monotherapy

Reporting group description

BMS-986249 2400 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 1A: BMS-986249 1600 mg Q8W Monotherapy

Reporting group description

BMS-986249 1600 mg IV every 8 weeks (Q8W), up to 2 years

Reporting group title

Part 1B: BMS-986249 240 mg Q4W + Nivo Combination

Reporting group description

BMS-986249 240 mg IV every 4 weeks (Q4W) + nivolumab 480 mg IV Q4W, up to 2 years

Reporting group title

Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination

Reporting group description

BMS-986249 800 mg IV every 4 weeks (Q4W) + nivolumab 480 mg IV Q4W, up to 2 years

Reporting group title

Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination

Reporting group description

BMS-986249 1200 mg IV every 4 weeks (Q4W) + nivolumab 480 mg IV Q4W, up to 2 years

Reporting group title

Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination

Reporting group description

BMS-986249 800 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 1B: BMS-986249 1200 mg Q8W+ Nivo Combination

Reporting group description

BMS-986249 1200 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination

Reporting group description

BMS-986249 1600 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 2A Arm A: BMS-986249 240 mg Q3W + Nivo 360 mg Q3W

Reporting group description

BMS-986249 240 mg IV every 3 weeks (Q3W) + nivolumab 360 mg IV every 3 weeks (Q3W) (4 doses), then nivolumab 480 mg IV every 4 weeks (Q4W) (maintenance), up to 2 years.

Reporting group title

Part 2A Arm B: BMS-986249 800 mg + Nivo 480 mg Q4W

Reporting group description

BMS-986249 800 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W

Reporting group description

BMS-986249 1200 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 2A Arm D: ipilimumab 3 mg/kg Q3W + Nivo 1 mg/kg Q3W

Reporting group description

Ipilimumab 3 mg/kg IV every 3 weeks (Q3W) + nivolumab 1 mg/kg IV Q3W (4 doses), then nivolumab 480 mg IV every 4 weeks (Q4W) monotherapy, up to 2 years.

Reporting group title

Part 2A Arm E: Nivo 480 mg Q4W Monotherapy

Reporting group description

Nivolumab 480 mg IV every 4 weeks (Q4W) monotherapy, up to 2 years.

Reporting group title

Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W

Reporting group description

BMS-986249 600 mg IV every 4 weeks (Q4W) + nivolumab 480 mg IV Q4W, up to 2 years.

Reporting group title

Part 2B: Cohort 1 (Advanced or Intermediate HCC)

Reporting group description

BMS-986249 1200 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Reporting group title

Part 2B: Cohort 2 (Metastatic CRPC)

Reporting group description

BMS-986249 1200 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years.

Reporting group title

Part 2B: Cohort 3 (Unresectable TNBC)

Reporting group description

BMS-986249 1200 mg IV every 8 weeks (Q8W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years.

Subject analysis set title

Part 2A Arm C: BMS-986249 1200 mg Q6W + Nivo 480 mg Q4W

Subject analysis set type

Per protocol

Subject analysis set description

BMS-986249 1200 mg IV every 6 weeks (Q6W) + nivol 480 mg IV every 4 weeks (Q4W)

Subject analysis set title

Part 2A Arm D: Ipilimumab 3 mg/kg Q3W + Nivo 1 mg/kg Q3W

Subject analysis set type

Per protocol

Subject analysis set description

Ipilimumab 3 mg/kg IV every 3 weeks (Q3W) + nivolumab 1 mg/kg IV Q3W (4 doses), then nivolumab 480 mg IV every 4 weeks (Q4W), monotherapy, up to 2 years.

Subject analysis set title

Part 2A Arm F: BMS-986249 1200 mg Q6W + Nivo 480 mg Q4W

Subject analysis set type

Per protocol

Subject analysis set description

BMS-986249 1200 mg IV every 6 weeks (Q6W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years.

Subject analysis set title

Part 2B: Cohort 1 (Advanced or Intermediate HCC):

Subject analysis set type

Per protocol

Subject analysis set description

BMS-986249 1200 mg IV every 6 weeks (Q6W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years.

Subject analysis set title

Part 2B Cohort 2 (Metastatic CRPC)

Subject analysis set type

Per protocol

Subject analysis set description

BMS-986249 1200 mg IV every 6 weeks (Q6W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years.

Subject analysis set title

Part 2B: Cohort 3 (Unresectable TNBC)

Subject analysis set type

Per protocol

Subject analysis set description

BMS-986249 1200 mg IV every 6 weeks (Q6W) + nivolumab 480 mg IV every 4 weeks (Q4W), up to 2 years

Primary: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part 1 A and 1 B

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End point title

Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part 1 A and 1 B ^[1] ^[2]

End point description

Adverse Events (AEs): Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment. Serious Adverse Events (SAEs): Serious adverse events are adverse events that result in death, are life-threatening, require hospitalization or prolong existing hospitalization, cause significant disability or incapacity, or result in a birth defect.

End point type

Primary

End point timeframe

From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

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: No further statistical analysis done for this endpoint
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: as per protocol, these are the defined arms for this endpoint

End point values	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivo Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W
Number of subjects analysed	6	11	10	1	11	12	11	9	13	10	9
Units: Participants
Adverse events (AEs)	6	11	10	1	11	12	11	9	13	10	9
Serious adverse events (SAEs)	4	8	8	1	7	8	7	7	10	8	7
Adverse events (AEs) leading to discontinuation	0	2	4	0	2	3	5	4	2	5	3

No statistical analyses for this end point

Primary: Number of participants with Adverse Events (AEs) meeting Protocol-Defined Dose-Limiting Toxicity (DLT) Criteria - Part 1 A and 1 B

Top of page

End point title

Number of participants with Adverse Events (AEs) meeting Protocol-Defined Dose-Limiting Toxicity (DLT) Criteria - Part 1 A and 1 B ^[3] ^[4]

End point description

Dose-limiting toxicities (DLTs) were defined by the incidence, intensity, and duration of adverse events (AEs) possibly related to study treatment during the 5-week (35-day) DLT evaluation period for both BMS-986249 monotherapy and combination therapy. Participants who received at least 2 doses and completed or discontinued due to a DLT within this period were considered DLT-evaluable. Those who withdrew or received less than 2 doses for reasons other than a DLT were not DLT-evaluable and could be replaced. Any drug-related AE meeting DLT criteria resulted in discontinuation of study treatment. DLTs guided dose escalation and helped define the maximum tolerated dose (MTD) and recommended Phase 2 dose (RP2D).

End point type

Primary

End point timeframe

From first dose until 5 weeks after first dose of study medicine (up to approximately 5 weeks)

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: No further statistical analysis done for this endpoint
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: as per protocol, these are the defined arms for this endpoint

End point values	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivo Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W
Number of subjects analysed	6	11	10	1	11	12	11	9	13	10	9
Units: Participants	0	0	1	0	1	0	1	0	0	3	0

No statistical analyses for this end point

Primary: Number of Participants who Died – Part 1 A and 1 B

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End point title

Number of Participants who Died – Part 1 A and 1 B ^[5] ^[6]

End point description

End point type

Primary

End point timeframe

From enrollment until the date of death from any cause (up to approximately 83 months)

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: No further statistical analysis done for this endpoint
[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: as per protocol, these are the defined arms for this endpoint

End point values	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivo Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W
Number of subjects analysed	6	11	10	1	11	12	11	9	13	10	9
Units: Participants	4	10	7	1	6	11	8	7	8	9	4

No statistical analyses for this end point

Primary: Number of Participants with Shifts from Baseline in Laboratory Test results – Part 1 A and 1 B

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End point title

Number of Participants with Shifts from Baseline in Laboratory Test results – Part 1 A and 1 B ^[7] ^[8]

End point description

Number of Participants with Shifts from Baseline in Laboratory Tests

End point type

Primary

End point timeframe

From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

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: No further statistical analysis done for this endpoint
[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: as per protocol, these are the defined arms for this endpoint

End point values	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivo Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W
Number of subjects analysed	6	11	9	1	11	12	11	9	13	10	9
Units: Participants
HEMOGLOBIN	3	4	7	1	4	10	9	6	7	7	4
PLATELET COUNT	1	1	2	0	0	0	3	0	2	3	1
LEUKOCYTES, LOCAL LAB	1	0	1	0	2	3	4	0	2	3	1
ABSOLUTE NEUTROPHIL COUNT DRV	0	0	0	0	2	0	4	0	1	2	2
LYMPHOCYTES (ABSOLUTE)	2	1	3	0	0	0	1	0	2	0	2
LYMPHOCYTES (ABSOLUTE), LOCAL LAB	2	7	6	0	3	6	5	5	1	4	6
CREATININE, LOCAL LAB	0	4	1	0	1	1	1	1	3	5	2
ALKALINE PHOSPHATASE (ALP) LOCAL LAB	1	7	1	1	3	5	4	6	5	6	2
ALANINE AMINOTRANSFERASE (ALT), LOCAL LAB	2	4	2	0	2	4	4	4	5	4	3
ASPARTATE AMINOTRANSFERASE (AST), LOCAL LAB	2	7	3	1	3	4	6	4	5	5	3
BILIRUBIN, TOTAL, LOCAL LAB	2	1	1	1	1	1	5	2	4	2	3

No statistical analyses for this end point

Primary: Number of Participants with Treatment-Related Grade 3-5 Adverse Events (AEs) Within 24 weeks – Part 2 A Arms C, D and F, and Part 2 B

Top of page

End point title

Number of Participants with Treatment-Related Grade 3-5 Adverse Events (AEs) Within 24 weeks – Part 2 A Arms C, D and F, and Part 2 B ^[9] ^[10]

End point description

Adverse Events (AEs): Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment. Grade 1: Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; no intervention needed. Grade 2: Moderate; minimal, local, or noninvasive intervention indicated; limiting age-appropriate activities. Grade 3: Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling. Grade 4: Life-threatening consequences; urgent intervention required. Grade 5: Death related to the adverse event.

End point type

Primary

End point timeframe

From first dose until 24 weeks after first dose (up to approximately 24 weeks)

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: No further statistical analysis done for this endpoint
[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: as per protocol, these are the defined arms for this endpoint

End point values	Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W	Part 2A Arm D: ipilimumab 3 mg/kg Q3W + Nivo 1 mg/kg Q3W	Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC)	Part 2B: Cohort 2 (Metastatic CRPC)	Part 2B: Cohort 3 (Unresectable TNBC)
Number of subjects analysed	58	59	36	5	41	45
Units: Participants	24	18	14	4	13	11

No statistical analyses for this end point

Primary: Objective Response Rate (ORR) as Assessed by Investigator - Part 2 A Arm C and F

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End point title

Objective Response Rate (ORR) as Assessed by Investigator - Part 2 A Arm C and F ^[11] ^[12]

End point description

Objective response rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to <10mm. Partial Response (PR): At least a30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

End point type

Primary

End point timeframe

From randomization until progression or death from any cause (up to approximately 83 months)

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: No further statistical analysis done for this endpoint
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: as per protocol, these are the defined arms for this endpoint

End point values	Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W	Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W
Number of subjects analysed	58	36
Units: Percentage of participants
number (confidence interval 95%)	36.2 (24.0 to 49.9)	52.8 (35.5 to 69.6)

No statistical analyses for this end point

Secondary: Time to Deterioration in Part 2A (Arm C, D and F)

Top of page

End point title

Time to Deterioration in Part 2A (Arm C, D and F) ^[13]

End point description

TTD in Global Health Status/QoL and Physical Functioning will be defined as the time from randomization until a clinically meaningful decline (i.e., reduction ≥10 points) from baseline in EORTC QLQ-C30 global health/quality of life subscale score and Physical Functioning Scale score.

End point type

Secondary

End point timeframe

Approximately up to 6 months

Notes
[13] - 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: as per protocol, these are the defined arms for this endpoint

End point values	Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W	Part 2A Arm D: ipilimumab 3 mg/kg Q3W + Nivo 1 mg/kg Q3W	Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W
Number of subjects analysed	58	59	36
Units: Months
median (confidence interval 95%)	3.52 (1.87 to 5.29)	4.37 (1.51 to 5.78)	2.79 (1.22 to 5.65)

No statistical analyses for this end point

Secondary: Safety Related Events in Part 2A (Arm C, D and F) and 2B

Top of page

End point title

Safety Related Events in Part 2A (Arm C, D and F) and 2B ^[14]

End point description

Adverse Events (AEs): Adverse events are any unwanted or harmful medical occurrences in a participant who receives a study drug or intervention. These events may or may not be related to the treatment. Serious Adverse Events (SAEs): Serious adverse events are adverse events that result in death, are life-threatening, require hospitalization or prolong existing hospitalization, cause significant disability or incapacity, or result in a birth defect.

End point type

Secondary

End point timeframe

From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

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: as per protocol, these are the defined arms for this endpoint

End point values	Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W	Part 2A Arm D: ipilimumab 3 mg/kg Q3W + Nivo 1 mg/kg Q3W	Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC)	Part 2B: Cohort 2 (Metastatic CRPC)	Part 2B: Cohort 3 (Unresectable TNBC)
Number of subjects analysed	57	58	36	5	41	45
Units: Template
Adverse Events	57	57	35	5	40	45
Serious Adverse Events	41	28	20	5	29	25
AEs leading to discontinuation	24	25	20	4	13	13
Deaths	27	24	10	4	26	28

No statistical analyses for this end point

Secondary: BOR of PSA and PCWG3 Response Rate in Part 2B Cohort 2

Top of page

End point title

BOR of PSA and PCWG3 Response Rate in Part 2B Cohort 2 ^[15]

End point description

Best Overall Response (BOR) is defined as the best response recorded from the start of randomization or first dosing date until the date of objectively documented PD based on RECIST v1.1 criteria or PCWG3 (for prostate cancer), or the date of subsequent therapy (including tumor directed radiotherapy and tumor-directed surgery which are not for palliative purpose), whichever occurs first.

End point type

Secondary

End point timeframe

From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)

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: as per protocol, these are the defined arms for this endpoint

End point values	Part 2B: Cohort 2 (Metastatic CRPC)
Number of subjects analysed	41
Units: Percentage of participants
number (confidence interval 95%)
PSA Response Rate	14.6 (5.6 to 29.2)
PCWG3 Response Rate	9.8 (2.7 to 23.1)

No statistical analyses for this end point

Secondary: Progression Free Survival

Top of page

End point title

Progression Free Survival ^[16]

End point description

Defined as the time between the date of randomization (Part 2A), or first dosing for Part 1 and supplemental analysis in Part 2A, and the date of first documented tumor progression, based on investigator assessments (per RECIST v1.1 criteria or PCWG3), or death due to any cause, whichever occurs first. Here "-99999 and 99999" = NA

End point type

Secondary

End point timeframe

From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)

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: as per protocol, these are the defined arms for this endpoint

Part 1A: BMS-986249 240 mg Monotherapy

Part 1A: BMS-986249 800 mg Monotherapy

Part 1A: BMS-986249 1600 mg Monotherapy

Part 1A: BMS-986249 2400 mg Monotherapy

Part 1A: BMS-986249 1600 mg Q8W Monotherapy

Part 1B: BMS-986249 240 mg Q4W + Nivo Combination

Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination

Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination

Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination

Part 1B: BMS-986249 1200 mg Q8W+ Nivo Combination

Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination

Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W

Part 2A Arm D: ipilimumab 3 mg/kg Q3W + Nivo 1 mg/kg Q3W

Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W

Part 2B: Cohort 1 (Advanced or Intermediate HCC)

Part 2B: Cohort 2 (Metastatic CRPC)

Part 2B: Cohort 3 (Unresectable TNBC)

Number of subjects analysed

Units: Months

median (confidence interval 95%)

1.74 (1.41 to 99999)

1.77 (1.15 to 1.84)

1.69 (0.53 to 3.25)

3.55 (-99999 to 99999)

1.68 (1.05 to 99999)

2.33 (1.68 to 3.32)

1.71 (0.85 to 14.23)

3.32 (1.22 to 4.40)

1.92 (0.59 to 7.13)

1.91 (1.02 to 99999)

4.35 (0.92 to 12.45)

6.51 (4.90 to 12.52)

4.73 (2.89 to 9.76)

10.38 (6.74 to 99999)

2.99 (1.77 to 99999)

5.62 (3.68 to 8.28)

3.35 (1.84 to 5.36)

No statistical analyses for this end point

Secondary: Duration of Response

Top of page

End point title

Duration of Response ^[17]

End point description

Defined as the time between the date of first documented response (CR or PR) to the date of the first documented tumor progression, as determined by RECIST v1.1 or PCWG3 criteria, or death due to any cause, whichever occurs first. Subjects who start subsequent therapy without a prior reported progression will be censored at the last evaluable tumor assessments prior to initiation of the subsequent anticancer therapy. Subjects who die without a reported prior progression will be considered to have progressed on the date of their death. Subjects who neither progress nor die, DOR will be censored on the date of their last evaluable tumor assessment. DOR will be evaluated for responders (confirmed CR or PR) only. Here "99999" = NA

End point type

Secondary

End point timeframe

From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)

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: as per protocol, these are the defined arms for this endpoint

Part 1A: BMS-986249 240 mg Monotherapy

Part 1A: BMS-986249 800 mg Monotherapy

Part 1A: BMS-986249 1600 mg Monotherapy

Part 1A: BMS-986249 2400 mg Monotherapy

Part 1A: BMS-986249 1600 mg Q8W Monotherapy

Part 1B: BMS-986249 240 mg Q4W + Nivo Combination

Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination

Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination

Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination

Part 1B: BMS-986249 1200 mg Q8W+ Nivo Combination

Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination

Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W

Part 2A Arm D: ipilimumab 3 mg/kg Q3W + Nivo 1 mg/kg Q3W

Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W

Part 2B: Cohort 1 (Advanced or Intermediate HCC)

Part 2B: Cohort 2 (Metastatic CRPC)

Part 2B: Cohort 3 (Unresectable TNBC)

Number of subjects analysed

0 ^[18]

0 ^[19]

0 ^[20]

0 ^[21]

0 ^[22]

0 ^[23]

0 ^[24]

0 ^[25]

Units: Months

median (full range (min-max))

( to )

99999 (12.48 to 99999)

( to )

15.80 (1.68 to 99999)

99999 (1.74 to 99999)

99999 (8.97 to 99999)

26.84 (7.85 to 99999)

99999 (7.2 to 99999)

99999 (6.47 to 99999)

( to )

99999 (99999 to 99999)

21.49 (3.68 to 99999)

Notes
[18] - No subjects with events
[19] - No subjects with events
[20] - No subjects with events
[21] - No subjects with events
[22] - No subjects with events
[23] - No subjects with events
[24] - No subjects with events
[25] - No subjects with events

No statistical analyses for this end point

Secondary: Time to Response

Top of page

End point title

Time to Response ^[26]

End point description

From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)

End point type

Secondary

End point timeframe

From first dose to first objective response (Approximately up to 3 Months)

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: as per protocol, these are the defined arms for this endpoint

Part 1A: BMS-986249 240 mg Monotherapy

Part 1A: BMS-986249 800 mg Monotherapy

Part 1A: BMS-986249 1600 mg Monotherapy

Part 1A: BMS-986249 2400 mg Monotherapy

Part 1A: BMS-986249 1600 mg Q8W Monotherapy

Part 1B: BMS-986249 240 mg Q4W + Nivo Combination

Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination

Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination

Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination

Part 1B: BMS-986249 1200 mg Q8W+ Nivo Combination

Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination

Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W

Part 2A Arm D: ipilimumab 3 mg/kg Q3W + Nivo 1 mg/kg Q3W

Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W

Part 2B: Cohort 1 (Advanced or Intermediate HCC)

Part 2B: Cohort 2 (Metastatic CRPC)

Part 2B: Cohort 3 (Unresectable TNBC)

Number of subjects analysed

0 ^[27]

0 ^[28]

0 ^[29]

0 ^[30]

0 ^[31]

0 ^[32]

0 ^[33]

0 ^[34]

Units: Months

median (full range (min-max))

( to )

2.76 (1.8 to 3.7)

( to )

1.74 (1.7 to 3.9)

3.48 (3.48 to 5.4)

4.01 (3.5 to 4.3)

2.86 (2.1 to 8.6)

2.83 (2.0 to 26.4)

2.83 (2.66 to 4.44)

( to )

2.84 (1.7 to 3.9)

1.87 (1.74 to 2.76)

Notes
[27] - No Subjects with Events
[28] - No Subjects with Events
[29] - No Subjects with Events
[30] - No Subjects with Events
[31] - No Subjects with Events
[32] - No Subjects with Events
[33] - No Subjects with Events
[34] - No Subjects with Events

No statistical analyses for this end point

Secondary: ORR by Investigator

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End point title

ORR by Investigator ^[35]

End point description

Objective response rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Prostate Cancer Working Group (PCWG) 3. For both RECIST v1.1 and PCWG3: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to <10mm. Partial Response (PR): At least a30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

End point type

Secondary

End point timeframe

From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)

Notes
[35] - 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: as per protocol, these are the defined arms for this endpoint

Part 1A: BMS-986249 240 mg Monotherapy

Part 1A: BMS-986249 800 mg Monotherapy

Part 1A: BMS-986249 1600 mg Monotherapy

Part 1A: BMS-986249 2400 mg Monotherapy

Part 1A: BMS-986249 1600 mg Q8W Monotherapy

Part 1B: BMS-986249 240 mg Q4W + Nivo Combination

Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination

Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination

Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination

Part 1B: BMS-986249 1200 mg Q8W+ Nivo Combination

Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination

Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W

Part 2A Arm D: ipilimumab 3 mg/kg Q3W + Nivo 1 mg/kg Q3W

Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W

Part 2B: Cohort 1 (Advanced or Intermediate HCC)

Part 2B: Cohort 2 (Metastatic CRPC)

Part 2B: Cohort 3 (Unresectable TNBC)

Number of subjects analysed

Units: Percentage of participants

number (confidence interval 95%)

0 (0.0 to 45.9)

0 (0.0 to 28.5)

0 (0.0 to 30.8)

0 (0.0 to 97.5)

0 (0.0 to 28.5)

0 (0.0 to 26.5)

18.2 (2.3 to 51.8)

0 (0.0 to 33.6)

23.1 (5.0 to 53.8)

33.3 (7.5 to 70.1)

30.0 (6.7 to 65.2)

36.2 (24.0 to 49.9)

35.6 (23.6 to 49.1)

52.8 (35.5 to 69.6)

0 (0.0 to 52.2)

9.8 (2.7 to 23.1)

15.6 (6.5 to 29.5)

No statistical analyses for this end point

Secondary: Objective Response Rate (ORR) as Assessed by Investigator - Part 1 A, 1B, 2A (Arms C,D,F) and 2B

Top of page

End point title

Objective Response Rate (ORR) as Assessed by Investigator - Part 1 A, 1B, 2A (Arms C,D,F) and 2B ^[36]

End point description

Objective response rate (ORR) is defined as the percent of participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or Prostate Cancer Working Group (PCWG) 3. For both RECIST v1.1 and PCWG3: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must also have reduction in the short axis to <10mm. Partial Response (PR): At least a30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.

End point type

Secondary

End point timeframe

From first dose (Parts 1 A and B) or randomization (Part 2 B) progression or death from any cause (up to approximately 83 months)

Notes
[36] - 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: as per protocol, these are the defined arms for this endpoint

Part 1A: BMS-986249 240 mg Monotherapy

Part 1A: BMS-986249 800 mg Monotherapy

Part 1A: BMS-986249 1600 mg Monotherapy

Part 1A: BMS-986249 2400 mg Monotherapy

Part 1A: BMS-986249 1600 mg Q8W Monotherapy

Part 1B: BMS-986249 240 mg Q4W + Nivo Combination

Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination

Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination

Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination

Part 1B: BMS-986249 1200 mg Q8W+ Nivo Combination

Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination

Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W

Part 2A Arm D: ipilimumab 3 mg/kg Q3W + Nivo 1 mg/kg Q3W

Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W

Number of subjects analysed

Units: Percentage of participants

number (confidence interval 95%)

0 (0.0 to 45.9)

0 (0.0 to 28.5)

0 (0.0 to 30.8)

0 (0.0 to 97.5)

0 (0.0 to 28.5)

0 (0.0 to 26.5)

18.2 (2.3 to 51.8)

0 (0.0 to 33.6)

23.1 (5.0 to 53.8)

33.3 (7.5 to 70.1)

30.0 (6.7 to 65.2)

31.0 (19.5 to 44.5)

27.1 (16.4 to 40.3)

50.0 (32.9 to 67.1)

No statistical analyses for this end point

Secondary: Cmax and Ctau of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B

Top of page

End point title

Cmax and Ctau of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B ^[37]

End point description

Cmax: The highest concentration of BMS-986249 in the blood after dosing. Ctau: The concentration of BMS-986249 in the blood at the end of a dosing interval, just before the next dose Here "99999" = NA

End point type

Secondary

End point timeframe

On Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (each cycle=28 days)

Notes
[37] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: as per protocol, these are the defined arms for this endpoint

End point values	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivo Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivo Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W	Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC)	Part 2B: Cohort 2 (Metastatic CRPC)	Part 2B: Cohort 3 (Unresectable TNBC)
Number of subjects analysed	5	11	10	1	11	12	11	8	13	9	10	56	33	5	39	38
Units: ng/mL
geometric mean (geometric coefficient of variation)
Cmax Cycle 1 Day 1	398 ( 24 )	1451 ( 39 )	3569 ( 27 )	4965 ( 99999 )	2735 ( 31 )	454 ( 27 )	1322 ( 40 )	1729 ( 39 )	1397 ( 27 )	2105 ( 26 )	3146 ( 38 )	2274 ( 49 )	1114 ( 34 )	1752 ( 40 )	2050 ( 27 )	2404 ( 41 )
Cmax C3D1	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	2919 ( 48 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1894 ( 33 )	1817 ( 32 )	2771 ( 28 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
Cmax Cycle 4 Day 1	432 ( 55 )	1425 ( 14 )	5299 ( 99999 )	3910 ( 99999 )	99999 ( 99999 )	570 ( 9 )	1706 ( 21 )	1436 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	930 ( 38 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
Cmax C5D1	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	2022 ( 50 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
Ctau Cycle 1 Day 1	7.69 ( 4151 )	174 ( 71 )	344 ( 418 )	385 ( 99999 )	52.6 ( 181 )	45.8 ( 322 )	143 ( 51 )	159 ( 58 )	20.2 ( 206 )	99999 ( 99999 )	58.7 ( 190 )	57.9 ( 300 )	153 ( 34 )	82.3 ( 61 )	79.3 ( 98 )	66.2 ( 153 )
Ctau C3D1	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	149 ( 24 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	94.4 ( 7 )	99999 ( 99999 )	152 ( 45 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
Ctau Cycle 4 Day 1	51.6 ( 255 )	1425 ( 14 )	99999 ( 99999 )	236 ( 99999 )	99999 ( 99999 )	170 ( 11 )	115 ( 310 )	107 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	151 ( 53 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
CTau C5D1	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	100 ( 83 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )

No statistical analyses for this end point

Secondary: AUC(0-T) and AUC(TAU) of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B

Top of page

End point title

AUC(0-T) and AUC(TAU) of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B ^[38]

End point description

AUC(0-T): The total amount of BMS-986249 in the blood from the time it is given until a specific time point. AUC(TAU): The total amount of BMS-986249 in the blood over one dosing interval Here "99999" = NA

End point type

Secondary

End point timeframe

On Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (each cycle=28 days)

Notes
[38] - 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: as per protocol, these are the defined arms for this endpoint

End point values	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivo Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivo Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W	Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC)	Part 2B: Cohort 2 (Metastatic CRPC)	Part 2B: Cohort 3 (Unresectable TNBC)
Number of subjects analysed	5	11	10	1	11	12	11	8	13	9	10	56	33	5	39	38
Units: ng*h/mL
geometric mean (geometric coefficient of variation)
AUC (0-T) Cycle 1 Day 1	77826 ( 48 )	294432 ( 39 )	745654 ( 40 )	991294 ( 99999 )	671019 ( 48 )	96709 ( 49 )	292555 ( 32 )	378115 ( 31 )	325275 ( 35 )	521156 ( 36 )	688556 ( 29 )	612513 ( 44 )	255384 ( 23 )	653770 ( 7 )	638435 ( 24 )	696815 ( 34 )
AUC (Tau) Cycle 1 Day 1	67094 ( 53 )	288621 ( 37 )	629431 ( 55 )	999415 ( 99999 )	484593 ( 74 )	88780 ( 61 )	282516 ( 32 )	326037 ( 40 )	259533 ( 35 )	458972 ( 41 )	532540 ( 43 )	464205 ( 81 )	231346 ( 48 )	407104 ( 56 )	438370 ( 70 )	554691 ( 52 )
AUC (0-T) Cycle 4 Day 1	432 ( 55 )	284353 ( 45 )	99999 ( 99999 )	687899 ( 99999 )	99999 ( 99999 )	181278 ( 9 )	338096 ( 49 )	255093 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	260319 ( 35 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
AUC (Tau) Cycle 4 Day 1	51.6 ( 255 )	147763 ( 25 )	114154 ( 99999 )	536764 ( 99999 )	99999 ( 99999 )	139951 ( 71 )	223315 ( 64 )	255093 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	229430 ( 37 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
AUC (0-T) C3D1	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1121470 ( 53 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	611831 ( 19 )	780896 ( 45 )	972214 ( 28 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
AUC (Tau) C3D1	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1121470 ( 53 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	611831 ( 19 )	780896 ( 45 )	937806 ( 25 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
AUC (0-T) C5D1	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	675816 ( 33 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
AUC (Tau) C5D1	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	564180 ( 52 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )

No statistical analyses for this end point

Secondary: Accumulation Index for Cmax (AI_Cmax) and Accumulation Index for AUC (AI_AUC) of BMS-986249 - Part 1 A and B, Part 2 A Arms C, D and F, Part 2 B

Top of page

End point title

Accumulation Index for Cmax (AI_Cmax) and Accumulation Index for AUC (AI_AUC) of BMS-986249 - Part 1 A and B, Part 2 A Arms C, D and F, Part 2 B ^[39]

End point description

AI_Cmax: How much the highest concentration of BMS-986249 increases after multiple doses compared to a single dose. AI_AUC: How much the total exposure to BMS-986249 increases after multiple doses compared to a single dose. Here "99999" = NA

End point type

Secondary

End point timeframe

On Cycle 1 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1 (each cycle=28 days)

Notes
[39] - 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: as per protocol, these are the defined arms for this endpoint

End point values	Part 1A: BMS-986249 240 mg Monotherapy	Part 1A: BMS-986249 800 mg Monotherapy	Part 1A: BMS-986249 1600 mg Monotherapy	Part 1A: BMS-986249 2400 mg Monotherapy	Part 1A: BMS-986249 1600 mg Q8W Monotherapy	Part 1B: BMS-986249 240 mg Q4W + Nivo Combination	Part 1B: BMS-986249 800 mg Q4W+ Nivo Combination	Part 1B: BMS-986249 1200 mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800 mg Q8W + Nivolumab Combination	Part 1B: BMS-986249 1200 mg Q8W+ Nivo Combination	Part 1B: BMS-986249 1600 mg Q8W+ Nivolumab Combination	Part 2A Arm C: BMS-986249 1200 mg Q8W + Nivo 480 mg Q4W	Part 2A Arm F: BMS-986249 600 mg Q4W + Nivo 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC)	Part 2B: Cohort 2 (Metastatic CRPC)	Part 2B: Cohort 3 (Unresectable TNBC)
Number of subjects analysed	5	11	10	1	11	12	11	8	13	9	10	56	33	5	39	38
Units: ratio
geometric mean (geometric coefficient of variation)
AI (AUC) Cycle 1 Day 1	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
AI Cmax Cycle 1 Day 1	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
AI (AUC) Cycle 4 Day 1	1.29 ( 11 )	1.07 ( 29 )	99999 ( 99999 )	0.694 ( 99999 )	99999 ( 99999 )	1.54 ( 1 )	1.23 ( 16 )	1.29 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	0.971 ( 24 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
AI Cmax Cycle 4 Day 1	1.02 ( 14 )	324 ( 99999 )	1.32 ( 99999 )	0.788 ( 99999 )	99999 ( 99999 )	1.28 ( 10 )	1.25 ( 17 )	1.62 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	0.899 ( 64 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
AI (AUC) C3D1	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1.35 ( 7 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1.82 ( 43 )	1.3 ( 17 )	1.46 ( 11 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
AI Cmax C3D1	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1.17 ( 3 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1.58 ( 85 )	0.918 ( 16 )	0.978 ( 14 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
AI (AUC) C5D1	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1.13 ( 18 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
AI Cmax C5D1	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1.11 ( 53 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )

No statistical analyses for this end point

Secondary: Number of Participants with Shifts from Baseline in Laboratory Test results – Part 2A (Arms C and F) and 2B

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End point title

Number of Participants with Shifts from Baseline in Laboratory Test results – Part 2A (Arms C and F) and 2B

End point description

End point type

Secondary

End point timeframe

From first dose until 100 days after last dose of study therapy (up to approximately 38 weeks)

End point values	Part 2A Arm C: BMS-986249 1200 mg Q6W + Nivo 480 mg Q4W	Part 2A Arm D: Ipilimumab 3 mg/kg Q3W + Nivo 1 mg/kg Q3W	Part 2A Arm F: BMS-986249 1200 mg Q6W + Nivo 480 mg Q4W	Part 2B: Cohort 1 (Advanced or Intermediate HCC):	Part 2B Cohort 2 (Metastatic CRPC)	Part 2B: Cohort 3 (Unresectable TNBC)
Number of subjects analysed	57	58	36	5	41	45
Units: Participants
HEMOGLOBIN	42	43	25	3	32	33
PLATELET COUNT	13	10	7	2	15	12
LEUKOCYTES, LOCAL LAB	12	10	6	0	9	14
ABSOLUTE NEUTROPHIL COUNT DRV	7	8	6	0	9	10
LYMPHOCYTES (ABSOLUTE)	9	19	10	0	11	11
LYMPHOCYTES (ABSOLUTE), LOCAL LAB	23	12	10	2	9	17
CREATININE, LOCAL LAB	20	17	10	3	14	5
ALKALINE PHOSPHATASE (ALP) LOCAL LAB	24	30	19	3	17	25
ALANINE AMINOTRANSFERASE (ALT), LOCAL LAB	38	40	23	4	18	27
ASPARTATE AMINOTRANSFERASE (AST), LOCAL LAB	27	40	22	3	19	31
BILIRUBIN, TOTAL, LOCAL LAB	12	18	7	3	12	5

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 38 weeks All-Cause mortality (From randomization to end of study): Approximately 83 Months

Adverse event reporting additional description

The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

27.1

Reporting group title

Part 1A: BMS-986249 Monotherapy 2400 Q4W

Reporting group description

BMS-986249 2400 mg IV Q4W, up to 2 years

Reporting group title

Part 1A: BMS-986249 Monotherapy 1600 Q4W

Reporting group description

BMS-986249 1600 mg IV Q4W, up to 2 years

Reporting group title

Part 1A: BMS-986249 Monotherapy BMS 800 Q4W

Reporting group description

BMS-986249 800 mg IV Q4W, up to 2 years

Reporting group title

Part 1A: BMS-986249 Monotherapy 240 mg IV Q4W

Reporting group description

BMS-986249 240 mg IV Q4W, up to 2 years

Reporting group title

Part 1A: BMS-986249 Monotherapy 1600 Q8W

Reporting group description

BMS-986249 1600 mg IV Q8W, up to 2 years

Reporting group title

Part 1B: BMS-986249 800mg Q8W+ Nivolumab Combination

Reporting group description

BMS-986249 800 mg IV Q8W + Nivolumab 480 mg IV Q8W

Reporting group title

Part 1B: BMS-986249 1200mg Q4W + Nivolumab Combination

Reporting group description

BMS-986249 1200 mg IV Q4W + Nivolumab 480 mg IV Q6W

Reporting group title

Part 1B: BMS-986249 800mg Q4W + Nivolumab Combination

Reporting group description

BMS-986249 800 mg IV Q4W + Nivolumab 480 mg IV Q4W

Reporting group title

Part 1B: BMS-986249 240mg Q4W + Nivolumab Combination

Reporting group description

BMS-986249 240 mg IV Q4W + Nivolumab 480 mg IV Q4W

Reporting group title

Part 1B: BMS-986249 1200mg Q8W+ Nivolumab Combination

Reporting group description

BMS-986249 1200 mg IV Q8W + Nivolumab 480 mg IV Q8W

Reporting group title

Part 1B: BMS-986249 1600mg Q8W+ Nivolumab Combination

Reporting group description

BMS-986249 1600 mg IV Q8W + Nivolumab 480 mg IV Q4W

Reporting group title

Part 2A: Melanoma Arms BMS-986249 240mg IV Q3W

Reporting group description

BMS-986249 240 mg IV Q3W + Nivolumab 360 mg IV Q3W (14 doses), then Nivolumab 480 mg IV Q4W (maintenance)

Reporting group title

Part 2A: Melanoma Arms BMS-986249 800mg IV Q3W

Reporting group description

BMS-986249 800 mg IV Q3W + Nivolumab 480 mg IV Q3W (14 doses), then Nivolumab 480 mg IV Q4W (maintenance)

Reporting group title

Part 2A: Melanoma Arms BMS-986249 1200mg IV Q3W

Reporting group description

BMS-986249 1200 mg IV Q3W + Nivolumab 480 mg IV Q3W (14 doses), then Nivolumab 480 mg IV Q4W (maintenance)

Reporting group title

Part 2A: Melanoma Arms Ipilimumab 3mg/kg IV Q3W

Reporting group description

Ipilimumab 3 mg/kg IV Q3W + Nivolumab 1 mg/kg IV Q3W (4 doses), then Nivolumab 480 mg IV Q4W (maintenance), up to 2 years

Reporting group title

Part 2A: Melanoma Arms Nivolumab Mono

Reporting group description

Nivolumab 480 mg IV Q4W Monotherapy

Reporting group title

Part 2A: Melanoma Arms BMS-986249 600mg IV Q8W

Reporting group description

BMS-986249 600 mg IV Q8W + Nivolumab 480 mg IV Q8W (Melanoma-specific combination)

Reporting group title

Part 2B: Cohort 1 (HCC)

Reporting group description

BMS-986249 1200 mg IV Q8W + Nivolumab 480 mg IV Q8W

Reporting group title

Part 2B: Cohort 2 (Metastatic CRPC)

Reporting group description

BMS-986249 1200 mg IV Q8W + Nivolumab 480 mg IV Q8W

Reporting group title

Part 2B: Cohort 3 (Unresectable TNBC)

Reporting group description

BMS-986249 1200 mg IV Q8W + Nivolumab 480 mg IV Q8W

Part 1A: BMS-986249 Monotherapy 2400 Q4W

Part 1A: BMS-986249 Monotherapy 1600 Q4W

Part 1A: BMS-986249 Monotherapy BMS 800 Q4W

Part 1A: BMS-986249 Monotherapy 240 mg IV Q4W

Part 1A: BMS-986249 Monotherapy 1600 Q8W

Part 1B: BMS-986249 800mg Q8W+ Nivolumab Combination

Part 1B: BMS-986249 1200mg Q4W + Nivolumab Combination

Part 1B: BMS-986249 800mg Q4W + Nivolumab Combination

Part 1B: BMS-986249 240mg Q4W + Nivolumab Combination

Part 1B: BMS-986249 1200mg Q8W+ Nivolumab Combination

Part 1B: BMS-986249 1600mg Q8W+ Nivolumab Combination

Part 2A: Melanoma Arms BMS-986249 240mg IV Q3W

Part 2A: Melanoma Arms BMS-986249 800mg IV Q3W

Part 2A: Melanoma Arms BMS-986249 1200mg IV Q3W

Part 2A: Melanoma Arms Ipilimumab 3mg/kg IV Q3W

Part 2A: Melanoma Arms Nivolumab Mono

Part 2A: Melanoma Arms BMS-986249 600mg IV Q8W

Part 2B: Cohort 1 (HCC)

Part 2B: Cohort 2 (Metastatic CRPC)

Part 2B: Cohort 3 (Unresectable TNBC)

Total subjects affected by serious adverse events

subjects affected / exposed

1 / 1 (100.00%)

8 / 10 (80.00%)

8 / 11 (72.73%)

4 / 6 (66.67%)

7 / 11 (63.64%)

10 / 13 (76.92%)

7 / 9 (77.78%)

7 / 11 (63.64%)

8 / 12 (66.67%)

7 / 9 (77.78%)

8 / 10 (80.00%)

3 / 3 (100.00%)

1 / 3 (33.33%)

42 / 57 (73.68%)

28 / 58 (48.28%)

1 / 3 (33.33%)

20 / 36 (55.56%)

5 / 5 (100.00%)

29 / 41 (70.73%)

25 / 45 (55.56%)

number of deaths (all causes)

number of deaths resulting from adverse events

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

Malignant neoplasm progression

subjects affected / exposed

1 / 1 (100.00%)

1 / 10 (10.00%)

6 / 11 (54.55%)

3 / 6 (50.00%)

1 / 11 (9.09%)

3 / 13 (23.08%)

5 / 9 (55.56%)

4 / 11 (36.36%)

3 / 12 (25.00%)

2 / 9 (22.22%)

2 / 10 (20.00%)

0 / 3 (0.00%)

6 / 57 (10.53%)

6 / 58 (10.34%)

1 / 3 (33.33%)

3 / 36 (8.33%)

1 / 5 (20.00%)

4 / 41 (9.76%)

2 / 45 (4.44%)

occurrences causally related to treatment / all

0 / 1

0 / 6

0 / 3

0 / 1

0 / 3

0 / 5

0 / 4

0 / 3

0 / 2

0 / 0

0 / 6

0 / 1

0 / 3

0 / 1

0 / 4

0 / 2

deaths causally related to treatment / all

0 / 1

0 / 6

0 / 2

0 / 1

0 / 3

0 / 5

0 / 3

0 / 2

0 / 0

0 / 6

0 / 1

0 / 3

0 / 0

0 / 4

0 / 2

Metastases to bone

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

1 / 6 (16.67%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metastases to spine

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metastatic malignant melanoma

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Neoplasm malignant

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

3 / 57 (5.26%)

2 / 58 (3.45%)

0 / 3 (0.00%)

0 / 36 (0.00%)

1 / 5 (20.00%)

4 / 41 (9.76%)

5 / 45 (11.11%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 2

0 / 0

0 / 1

0 / 4

0 / 5

deaths causally related to treatment / all

0 / 0

0 / 3

0 / 2

0 / 0

0 / 1

0 / 4

0 / 5

Neoplasm progression

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

1 / 11 (9.09%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

1 / 3 (33.33%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Tumour haemorrhage

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

1 / 9 (11.11%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Tumour pain

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

1 / 9 (11.11%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Arterial haemorrhage

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (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

Bleeding varicose vein

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

1 / 5 (20.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Deep vein thrombosis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Embolism

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

1 / 11 (9.09%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haemorrhage

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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 / 1 (0.00%)

1 / 10 (10.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vasculitis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Peripheral embolism

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Fatigue

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

1 / 11 (9.09%)

0 / 13 (0.00%)

2 / 9 (22.22%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

Oedema peripheral

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pain

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

1 / 11 (9.09%)

0 / 6 (0.00%)

1 / 11 (9.09%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (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

Performance status decreased

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Pyrexia

subjects affected / exposed

0 / 1 (0.00%)

1 / 10 (10.00%)

0 / 11 (0.00%)

1 / 6 (16.67%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

5 / 57 (8.77%)

1 / 58 (1.72%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

2 / 41 (4.88%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

6 / 9

1 / 1

0 / 0

2 / 4

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Sudden death

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Systemic inflammatory response syndrome

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Atelectasis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

1 / 11 (9.09%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dyspnoea

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 10 (0.00%)

1 / 3 (33.33%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

1 / 5 (20.00%)

1 / 41 (2.44%)

0 / 45 (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

Hypoxia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

1 / 11 (9.09%)

0 / 6 (0.00%)

1 / 11 (9.09%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

1 / 45 (2.22%)

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

Pleural effusion

subjects affected / exposed

0 / 1 (0.00%)

1 / 10 (10.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

1 / 13 (7.69%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

3 / 45 (6.67%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 3

deaths causally related to treatment / all

0 / 0

Pleuritic pain

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

1 / 11 (9.09%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumothorax

subjects affected / exposed

0 / 1 (0.00%)

1 / 10 (10.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonitis

subjects affected / exposed

0 / 1 (0.00%)

1 / 10 (10.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

1 / 11 (9.09%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

1 / 10 (10.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary embolism

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

2 / 11 (18.18%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory distress

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory failure

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

1 / 13 (7.69%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

2 / 57 (3.51%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 2

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

Psychiatric disorders

Confusional state

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

1 / 11 (9.09%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Investigations

Alanine aminotransferase increased

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

1 / 13 (7.69%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

1 / 10 (10.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Aspartate aminotransferase increased

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

1 / 13 (7.69%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

1 / 10 (10.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood alkaline phosphatase increased

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

1 / 13 (7.69%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

1 / 6 (16.67%)

0 / 11 (0.00%)

1 / 13 (7.69%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Blood creatinine increased

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Liver function test increased

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

1 / 6 (16.67%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Transaminases increased

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Troponin I increased

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

1 / 9 (11.11%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Fall

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

1 / 9 (11.11%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (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

Hip fracture

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 3 (33.33%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Humerus fracture

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

1 / 9 (11.11%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Subdural haematoma

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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 myocardial infarction

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

2 / 58 (3.45%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (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

Arrhythmia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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 / 1 (0.00%)

0 / 10 (0.00%)

1 / 11 (9.09%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Cardiac tamponade

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (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

Cardio-respiratory arrest

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

2 / 57 (3.51%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Immune-mediated myocarditis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Myocardial infarction

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Myocardial ischaemia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Myocarditis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pericardial effusion

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Supraventricular tachycardia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

1 / 11 (9.09%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Brain oedema

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

1 / 9 (11.11%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cerebral haemorrhage

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (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

Cerebral infarction

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

2 / 58 (3.45%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (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

0 / 1

0 / 0

Cerebral ischaemia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Facial paresis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haemorrhage intracranial

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

1 / 9 (11.11%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Headache

subjects affected / exposed

0 / 1 (0.00%)

1 / 10 (10.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

1 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Paraparesis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Somnolence

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

1 / 11 (9.09%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Transient ischaemic attack

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tremor

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

1 / 11 (9.09%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

1 / 13 (7.69%)

1 / 9 (11.11%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (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

Aplasia pure red cell

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Febrile neutropenia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

1 / 9 (11.11%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haemolysis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haemolytic anaemia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Heparin-induced thrombocytopenia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

1 / 5 (20.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pancytopenia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Ear and labyrinth disorders

Vertigo

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Eye disorders

Uveitis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Abdominal pain

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

1 / 9 (11.11%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Ascites

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Autoimmune colitis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Colitis

subjects affected / exposed

0 / 1 (0.00%)

2 / 10 (20.00%)

1 / 11 (9.09%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

2 / 9 (22.22%)

0 / 11 (0.00%)

1 / 12 (8.33%)

2 / 9 (22.22%)

2 / 10 (20.00%)

1 / 3 (33.33%)

0 / 3 (0.00%)

2 / 57 (3.51%)

0 / 58 (0.00%)

0 / 3 (0.00%)

2 / 36 (5.56%)

2 / 5 (40.00%)

2 / 41 (4.88%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

2 / 2

0 / 0

3 / 3

0 / 0

1 / 1

3 / 4

2 / 2

1 / 1

0 / 0

4 / 4

0 / 0

2 / 2

3 / 3

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Colitis ulcerative

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diarrhoea

subjects affected / exposed

0 / 1 (0.00%)

2 / 10 (20.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

2 / 10 (20.00%)

0 / 3 (0.00%)

2 / 57 (3.51%)

3 / 58 (5.17%)

0 / 3 (0.00%)

4 / 36 (11.11%)

0 / 5 (0.00%)

0 / 41 (0.00%)

2 / 45 (4.44%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

1 / 1

0 / 0

4 / 4

0 / 0

2 / 2

3 / 3

0 / 0

4 / 4

0 / 0

1 / 2

deaths causally related to treatment / all

0 / 0

Duodenal ulcer

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastric haemorrhage

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Gastrointestinal haemorrhage

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune-mediated enterocolitis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

3 / 57 (5.26%)

0 / 58 (0.00%)

0 / 3 (0.00%)

2 / 36 (5.56%)

0 / 5 (0.00%)

2 / 41 (4.88%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

4 / 4

0 / 0

3 / 3

0 / 0

2 / 2

1 / 1

deaths causally related to treatment / all

0 / 0

Intestinal obstruction

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

1 / 11 (9.09%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (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 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

1 / 13 (7.69%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Odynophagia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

1 / 9 (11.11%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Oesophagitis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

1 / 9 (11.11%)

0 / 11 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Pancreatitis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pancreatitis acute

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

1 / 13 (7.69%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Portal hypertensive gastropathy

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Small intestinal obstruction

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

1 / 11 (9.09%)

1 / 13 (7.69%)

0 / 9 (0.00%)

1 / 11 (9.09%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Small intestinal perforation

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

1 / 13 (7.69%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Upper gastrointestinal haemorrhage

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Vomiting

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

1 / 13 (7.69%)

1 / 9 (11.11%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

1 / 3 (33.33%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Hepatobiliary disorders

Cholecystitis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

1 / 10 (10.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cholecystitis acute

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (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

Hepatitis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

2 / 57 (3.51%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatotoxicity

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypertransaminasaemia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune-mediated hepatic disorder

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune-mediated hepatitis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

2 / 58 (3.45%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Jaundice cholestatic

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

1 / 13 (7.69%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

0 / 1

Skin and subcutaneous tissue disorders

Acute generalised exanthematous pustulosis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Rash

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

1 / 9 (11.11%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rash maculo-papular

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

1 / 5 (20.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal and urinary disorders

Acute kidney injury

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

2 / 10 (20.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

1 / 5 (20.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 2

0 / 0

0 / 1

0 / 0

1 / 1

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune-mediated nephritis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Nephrolithiasis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Renal failure

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

1 / 3 (33.33%)

0 / 36 (0.00%)

1 / 5 (20.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary tract obstruction

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

1 / 9 (11.11%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (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

Tubulointerstitial nephritis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Endocrine disorders

Adrenal insufficiency

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

1 / 10 (10.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hyperthyroidism

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Hypophysitis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

1 / 10 (10.00%)

1 / 3 (33.33%)

0 / 3 (0.00%)

1 / 57 (1.75%)

1 / 58 (1.72%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypopituitarism

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

1 / 9 (11.11%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Immune-mediated hypophysitis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Thyroiditis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

1 / 5 (20.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Back pain

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

1 / 11 (9.09%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haematoma muscle

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

Musculoskeletal chest pain

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

1 / 11 (9.09%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Myositis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pathological fracture

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

2 / 58 (3.45%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Spinal stenosis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infections and infestations

Bacteraemia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

1 / 9 (11.11%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

COVID-19

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

1 / 10 (10.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

2 / 41 (4.88%)

0 / 45 (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

COVID-19 pneumonia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 3 (33.33%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Clostridium difficile colitis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

Device related infection

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (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

Encephalitis

subjects affected / exposed

0 / 1 (0.00%)

1 / 10 (10.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Enterocolitis infectious

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastroenteritis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal infection

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

1 / 11 (9.09%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Klebsiella urinary tract infection

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Listeriosis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Pneumonia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

1 / 11 (9.09%)

0 / 6 (0.00%)

0 / 11 (0.00%)

1 / 13 (7.69%)

0 / 9 (0.00%)

0 / 11 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

2 / 57 (3.51%)

1 / 58 (1.72%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

2 / 41 (4.88%)

3 / 45 (6.67%)

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 / 2

0 / 3

deaths causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

Pneumonia influenzal

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Post procedural infection

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Postoperative wound infection

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Pulmonary sepsis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (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

Pyelonephritis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Pyelonephritis acute

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory tract infection

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Sepsis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

2 / 13 (15.38%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

2 / 58 (3.45%)

0 / 3 (0.00%)

0 / 36 (0.00%)

1 / 5 (20.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

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

0 / 1

0 / 0

Septic shock

subjects affected / exposed

0 / 1 (0.00%)

1 / 10 (10.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Staphylococcal bacteraemia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (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

Upper respiratory tract infection

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

1 / 9 (11.11%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

1 / 13 (7.69%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

2 / 57 (3.51%)

0 / 58 (0.00%)

0 / 3 (0.00%)

1 / 36 (2.78%)

0 / 5 (0.00%)

3 / 41 (7.32%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 5

0 / 1

deaths causally related to treatment / all

0 / 0

Urosepsis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

2 / 41 (4.88%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 1

deaths causally related to treatment / all

0 / 0

Viral infection

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

1 / 57 (1.75%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metabolism and nutrition disorders

Diabetes mellitus

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diabetic ketoacidosis

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

1 / 45 (2.22%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Hypercalcaemia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hyperglycaemia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

1 / 58 (1.72%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Hypocalcaemia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypoglycaemia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

1 / 9 (11.11%)

0 / 11 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

0 / 41 (0.00%)

0 / 45 (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

Hyponatraemia

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

1 / 11 (9.09%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

2 / 41 (4.88%)

0 / 45 (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

Malnutrition

subjects affected / exposed

0 / 1 (0.00%)

0 / 10 (0.00%)

0 / 11 (0.00%)

0 / 6 (0.00%)

0 / 11 (0.00%)

0 / 13 (0.00%)

0 / 9 (0.00%)

0 / 11 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 10 (0.00%)

0 / 3 (0.00%)

0 / 57 (0.00%)

0 / 58 (0.00%)

0 / 3 (0.00%)

0 / 36 (0.00%)

0 / 5 (0.00%)

1 / 41 (2.44%)

0 / 45 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

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

Non-serious adverse events	Part 1A: BMS-986249 Monotherapy 2400 Q4W	Part 1A: BMS-986249 Monotherapy 1600 Q4W	Part 1A: BMS-986249 Monotherapy BMS 800 Q4W	Part 1A: BMS-986249 Monotherapy 240 mg IV Q4W	Part 1A: BMS-986249 Monotherapy 1600 Q8W	Part 1B: BMS-986249 800mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1200mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 800mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 240mg Q4W + Nivolumab Combination	Part 1B: BMS-986249 1200mg Q8W+ Nivolumab Combination	Part 1B: BMS-986249 1600mg Q8W+ Nivolumab Combination	Part 2A: Melanoma Arms BMS-986249 240mg IV Q3W	Part 2A: Melanoma Arms BMS-986249 800mg IV Q3W	Part 2A: Melanoma Arms BMS-986249 1200mg IV Q3W	Part 2A: Melanoma Arms Ipilimumab 3mg/kg IV Q3W	Part 2A: Melanoma Arms Nivolumab Mono	Part 2A: Melanoma Arms BMS-986249 600mg IV Q8W	Part 2B: Cohort 1 (HCC)	Part 2B: Cohort 2 (Metastatic CRPC)	Part 2B: Cohort 3 (Unresectable TNBC)
Total subjects affected by non serious adverse events
subjects affected / exposed	1 / 1 (100.00%)	9 / 10 (90.00%)	11 / 11 (100.00%)	6 / 6 (100.00%)	9 / 11 (81.82%)	12 / 13 (92.31%)	9 / 9 (100.00%)	11 / 11 (100.00%)	12 / 12 (100.00%)	9 / 9 (100.00%)	10 / 10 (100.00%)	3 / 3 (100.00%)	3 / 3 (100.00%)	57 / 57 (100.00%)	57 / 58 (98.28%)	3 / 3 (100.00%)	34 / 36 (94.44%)	5 / 5 (100.00%)	39 / 41 (95.12%)	45 / 45 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Malignant neoplasm progression
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0
Cancer pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 57 (5.26%)	5 / 58 (8.62%)	0 / 3 (0.00%)	3 / 36 (8.33%)	0 / 5 (0.00%)	2 / 41 (4.88%)	2 / 45 (4.44%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	3	5	0	3	0	2	3
Tumour pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	2 / 9 (22.22%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	0	1	0	1	0	1	0
Metastases to central nervous system
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	2 / 11 (18.18%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 57 (3.51%)	2 / 58 (3.45%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	2	2	0	0	0	1	0
Haematoma
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Haemorrhage
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	1 / 3 (33.33%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Hot flush
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	2	1	0	0	0	1	0	0	0	0	0
Hypertension
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 57 (5.26%)	7 / 58 (12.07%)	1 / 3 (33.33%)	4 / 36 (11.11%)	0 / 5 (0.00%)	5 / 41 (12.20%)	2 / 45 (4.44%)
occurrences all number	0	0	1	0	0	1	0	0	0	1	0	0	0	4	11	1	4	0	5	2
Hypotension
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 57 (7.02%)	3 / 58 (5.17%)	0 / 3 (0.00%)	3 / 36 (8.33%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	1	0	0	5	4	0	4	0	2	0
Pallor
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Venous thrombosis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	1
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	1 / 9 (11.11%)	1 / 11 (9.09%)	2 / 12 (16.67%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	13 / 57 (22.81%)	5 / 58 (8.62%)	1 / 3 (33.33%)	3 / 36 (8.33%)	0 / 5 (0.00%)	3 / 41 (7.32%)	7 / 45 (15.56%)
occurrences all number	0	0	0	0	0	3	1	1	2	0	1	0	0	15	6	1	3	0	3	7
Application site reaction
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Axillary pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 57 (5.26%)	0 / 58 (0.00%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	3	0	0	2	0	0	0
Chest discomfort
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	1 / 6 (16.67%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Chest pain
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	3 / 45 (6.67%)
occurrences all number	0	1	0	0	0	0	0	0	0	1	0	0	0	0	1	0	1	0	0	3
Chills
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	1 / 6 (16.67%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 57 (3.51%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	2 / 45 (4.44%)
occurrences all number	0	0	0	1	0	0	0	0	1	0	0	0	0	2	0	0	2	0	0	2
Complication associated with device
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Device related thrombosis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Gait disturbance
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	1 / 6 (16.67%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Fatigue
subjects affected / exposed	0 / 1 (0.00%)	7 / 10 (70.00%)	4 / 11 (36.36%)	1 / 6 (16.67%)	2 / 11 (18.18%)	7 / 13 (53.85%)	6 / 9 (66.67%)	6 / 11 (54.55%)	9 / 12 (75.00%)	6 / 9 (66.67%)	5 / 10 (50.00%)	0 / 3 (0.00%)	3 / 3 (100.00%)	15 / 57 (26.32%)	19 / 58 (32.76%)	0 / 3 (0.00%)	9 / 36 (25.00%)	4 / 5 (80.00%)	18 / 41 (43.90%)	13 / 45 (28.89%)
occurrences all number	0	7	5	1	2	8	7	6	9	8	6	0	3	18	26	0	11	4	21	17
Hernia pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Injection site extravasation
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Influenza like illness
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 57 (5.26%)	1 / 58 (1.72%)	0 / 3 (0.00%)	1 / 36 (2.78%)	2 / 5 (40.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	1	0	0	0	4	1	0	2	2	0	0
Localised oedema
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Mucosal inflammation
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 57 (3.51%)	5 / 58 (8.62%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	2 / 41 (4.88%)	3 / 45 (6.67%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	2	6	0	2	0	2	3
Malaise
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Non-cardiac chest pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	1	1	0	0	1	0	0	0
Oedema peripheral
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	2 / 11 (18.18%)	3 / 13 (23.08%)	2 / 9 (22.22%)	1 / 11 (9.09%)	2 / 12 (16.67%)	4 / 9 (44.44%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	7 / 57 (12.28%)	7 / 58 (12.07%)	0 / 3 (0.00%)	4 / 36 (11.11%)	1 / 5 (20.00%)	9 / 41 (21.95%)	3 / 45 (6.67%)
occurrences all number	0	1	1	0	2	3	2	1	2	4	0	0	0	8	8	0	5	1	9	3
Pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	2 / 11 (18.18%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	3 / 41 (7.32%)	2 / 45 (4.44%)
occurrences all number	0	0	0	0	2	0	0	0	1	0	0	0	0	0	0	0	0	0	3	2
Performance status decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Peripheral swelling
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	1	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Pyrexia
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	1 / 11 (9.09%)	1 / 6 (16.67%)	0 / 11 (0.00%)	4 / 13 (30.77%)	3 / 9 (33.33%)	4 / 11 (36.36%)	5 / 12 (41.67%)	1 / 9 (11.11%)	1 / 10 (10.00%)	1 / 3 (33.33%)	1 / 3 (33.33%)	14 / 57 (24.56%)	11 / 58 (18.97%)	0 / 3 (0.00%)	8 / 36 (22.22%)	3 / 5 (60.00%)	3 / 41 (7.32%)	14 / 45 (31.11%)
occurrences all number	0	1	1	1	0	4	6	5	8	1	1	1	2	23	23	0	15	4	3	19
Swelling face
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Xerosis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 57 (7.02%)	8 / 58 (13.79%)	1 / 3 (33.33%)	4 / 36 (11.11%)	0 / 5 (0.00%)	9 / 41 (21.95%)	3 / 45 (6.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	4	8	1	4	0	9	3
Temperature intolerance
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Immune system disorders
Seasonal allergy
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Reproductive system and breast disorders
Heavy menstrual bleeding
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Breast pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Vulvovaginal pruritus
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Apnoea
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Cough
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	2 / 11 (18.18%)	1 / 6 (16.67%)	1 / 11 (9.09%)	0 / 13 (0.00%)	1 / 9 (11.11%)	2 / 11 (18.18%)	2 / 12 (16.67%)	1 / 9 (11.11%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	8 / 57 (14.04%)	7 / 58 (12.07%)	0 / 3 (0.00%)	4 / 36 (11.11%)	0 / 5 (0.00%)	11 / 41 (26.83%)	13 / 45 (28.89%)
occurrences all number	0	1	2	1	1	0	1	3	2	1	1	0	0	9	8	0	6	0	12	14
Dysphonia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Dyspnoea
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	1 / 11 (9.09%)	1 / 6 (16.67%)	1 / 11 (9.09%)	0 / 13 (0.00%)	1 / 9 (11.11%)	1 / 11 (9.09%)	3 / 12 (25.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	6 / 57 (10.53%)	4 / 58 (6.90%)	0 / 3 (0.00%)	3 / 36 (8.33%)	0 / 5 (0.00%)	1 / 41 (2.44%)	8 / 45 (17.78%)
occurrences all number	0	1	2	1	2	0	1	1	3	0	0	0	1	6	5	0	3	0	1	9
Nasal congestion
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	0 / 11 (0.00%)	1 / 6 (16.67%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	2 / 58 (3.45%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	1	0	1	0	0	0	0	1	1	0	0	0	0	5	0	0	0	1	0
Hypoxia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	2 / 13 (15.38%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	2	0	1	0	0	1	0	0	0	0	0	0	0	0	0
Haemoptysis
subjects affected / exposed	1 / 1 (100.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	1 / 9 (11.11%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	1	0	0	0	0	1	1	0	1	0	0	0	0	0	0	0	0	0	1	0
Oropharyngeal pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	2 / 58 (3.45%)	0 / 3 (0.00%)	1 / 36 (2.78%)	1 / 5 (20.00%)	2 / 41 (4.88%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	5	0	1	1	2	0
Pleural effusion
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	1 / 11 (9.09%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	4 / 45 (8.89%)
occurrences all number	0	0	1	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	4
Pneumonitis
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 57 (5.26%)	2 / 58 (3.45%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	2 / 41 (4.88%)	3 / 45 (6.67%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	3	2	0	2	0	4	4
Pneumothorax
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	1 / 6 (16.67%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Pulmonary embolism
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	5 / 57 (8.77%)	3 / 58 (5.17%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	5	3	0	1	0	1	0
Rhinitis allergic
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0
Rhinorrhoea
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Upper-airway cough syndrome
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Wheezing
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Psychiatric disorders
Adjustment disorder with depressed mood
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Affective disorder
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	3 / 41 (7.32%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	1	0	3	0
Anxiety
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	1 / 9 (11.11%)	1 / 11 (9.09%)	3 / 12 (25.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	2 / 58 (3.45%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	1	1	1	3	0	0	0	0	0	2	0	2	0	0	1
Depression
subjects affected / exposed	1 / 1 (100.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	2 / 58 (3.45%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	2 / 41 (4.88%)	1 / 45 (2.22%)
occurrences all number	1	0	0	0	0	0	1	0	1	0	0	0	0	1	2	0	0	0	2	1
Disorientation
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Insomnia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	1 / 6 (16.67%)	0 / 11 (0.00%)	1 / 13 (7.69%)	2 / 9 (22.22%)	0 / 11 (0.00%)	2 / 12 (16.67%)	2 / 9 (22.22%)	2 / 10 (20.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 57 (5.26%)	5 / 58 (8.62%)	1 / 3 (33.33%)	2 / 36 (5.56%)	0 / 5 (0.00%)	5 / 41 (12.20%)	3 / 45 (6.67%)
occurrences all number	0	0	0	1	0	1	2	0	2	2	2	0	0	3	5	1	2	0	5	4
Libido decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Mental status changes
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Panic attack
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Investigations
Ammonia increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Alanine aminotransferase increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	1 / 6 (16.67%)	0 / 11 (0.00%)	3 / 13 (23.08%)	2 / 9 (22.22%)	1 / 11 (9.09%)	3 / 12 (25.00%)	2 / 9 (22.22%)	1 / 10 (10.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	25 / 57 (43.86%)	22 / 58 (37.93%)	1 / 3 (33.33%)	14 / 36 (38.89%)	2 / 5 (40.00%)	10 / 41 (24.39%)	16 / 45 (35.56%)
occurrences all number	0	0	1	1	0	3	3	2	3	3	2	0	3	36	34	1	21	2	13	25
Amylase increased
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	1 / 11 (9.09%)	2 / 6 (33.33%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	1 / 11 (9.09%)	2 / 12 (16.67%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	9 / 57 (15.79%)	7 / 58 (12.07%)	2 / 3 (66.67%)	6 / 36 (16.67%)	0 / 5 (0.00%)	1 / 41 (2.44%)	10 / 45 (22.22%)
occurrences all number	0	1	1	2	0	1	0	1	3	0	0	0	2	14	11	2	11	0	1	10
Blood albumin decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	4 / 57 (7.02%)	6 / 58 (10.34%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	4 / 41 (9.76%)	7 / 45 (15.56%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	5	7	0	1	0	8	9
Aspartate aminotransferase increased
subjects affected / exposed	1 / 1 (100.00%)	1 / 10 (10.00%)	2 / 11 (18.18%)	1 / 6 (16.67%)	1 / 11 (9.09%)	1 / 13 (7.69%)	2 / 9 (22.22%)	1 / 11 (9.09%)	2 / 12 (16.67%)	3 / 9 (33.33%)	2 / 10 (20.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	21 / 57 (36.84%)	25 / 58 (43.10%)	0 / 3 (0.00%)	10 / 36 (27.78%)	2 / 5 (40.00%)	8 / 41 (19.51%)	17 / 45 (37.78%)
occurrences all number	1	1	2	1	1	1	3	1	2	5	3	0	4	35	40	0	12	2	12	28
Blood bilirubin increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	1 / 6 (16.67%)	0 / 11 (0.00%)	1 / 13 (7.69%)	1 / 9 (11.11%)	1 / 11 (9.09%)	1 / 12 (8.33%)	1 / 9 (11.11%)	2 / 10 (20.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	3 / 57 (5.26%)	6 / 58 (10.34%)	1 / 3 (33.33%)	2 / 36 (5.56%)	2 / 5 (40.00%)	3 / 41 (7.32%)	4 / 45 (8.89%)
occurrences all number	0	0	0	1	0	2	1	1	1	1	2	0	2	5	8	5	3	3	3	4
Blood alkaline phosphatase increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	3 / 11 (27.27%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	3 / 9 (33.33%)	1 / 11 (9.09%)	2 / 12 (16.67%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 57 (7.02%)	7 / 58 (12.07%)	0 / 3 (0.00%)	1 / 36 (2.78%)	1 / 5 (20.00%)	1 / 41 (2.44%)	2 / 45 (4.44%)
occurrences all number	0	0	3	0	0	0	3	1	2	1	0	0	0	5	10	0	1	1	1	2
Blood calcium decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	5 / 57 (8.77%)	3 / 58 (5.17%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	4 / 41 (9.76%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	8	3	0	0	0	13	1
Blood calcium increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	2 / 58 (3.45%)	1 / 3 (33.33%)	2 / 36 (5.56%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	1	3	0	0	1
Blood cholesterol increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	5 / 57 (8.77%)	5 / 58 (8.62%)	1 / 3 (33.33%)	1 / 36 (2.78%)	0 / 5 (0.00%)	2 / 41 (4.88%)	6 / 45 (13.33%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	10	11	1	1	0	2	7
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	10 / 57 (17.54%)	10 / 58 (17.24%)	1 / 3 (33.33%)	2 / 36 (5.56%)	0 / 5 (0.00%)	2 / 41 (4.88%)	5 / 45 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	2	14	17	1	2	0	3	7
Blood creatinine increased
subjects affected / exposed	0 / 1 (0.00%)	2 / 10 (20.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	1 / 9 (11.11%)	1 / 11 (9.09%)	1 / 12 (8.33%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	12 / 57 (21.05%)	10 / 58 (17.24%)	0 / 3 (0.00%)	4 / 36 (11.11%)	1 / 5 (20.00%)	4 / 41 (9.76%)	1 / 45 (2.22%)
occurrences all number	0	3	1	0	0	2	2	1	1	0	1	0	1	16	19	0	4	1	5	1
Blood glucose decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	1
Blood lactic acid increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Blood glucose increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	10 / 57 (17.54%)	10 / 58 (17.24%)	1 / 3 (33.33%)	1 / 36 (2.78%)	0 / 5 (0.00%)	3 / 41 (7.32%)	5 / 45 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	3	15	14	1	1	0	3	10
Blood magnesium decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 57 (7.02%)	9 / 58 (15.52%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	2 / 41 (4.88%)	10 / 45 (22.22%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	9	13	0	2	0	2	12
Blood phosphorus increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0
Blood potassium decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 57 (5.26%)	1 / 58 (1.72%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	3 / 41 (7.32%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	3	1	0	2	0	3	1
Blood prolactin increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Blood sodium decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	6 / 57 (10.53%)	8 / 58 (13.79%)	1 / 3 (33.33%)	1 / 36 (2.78%)	1 / 5 (20.00%)	7 / 41 (17.07%)	5 / 45 (11.11%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	8	10	2	1	1	11	6
Blood thyroid stimulating hormone decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 57 (3.51%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	2 / 45 (4.44%)
occurrences all number	0	0	1	0	0	0	0	0	1	0	0	0	0	2	1	0	0	0	1	2
Blood thyroid stimulating hormone increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	9 / 57 (15.79%)	8 / 58 (13.79%)	1 / 3 (33.33%)	2 / 36 (5.56%)	0 / 5 (0.00%)	2 / 41 (4.88%)	6 / 45 (13.33%)
occurrences all number	0	0	0	0	1	0	0	0	1	0	0	0	1	10	10	1	2	0	2	6
Blood uric acid increased
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0
C-reactive protein increased
subjects affected / exposed	1 / 1 (100.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	1
Cardiac murmur
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	1 / 6 (16.67%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	7 / 57 (12.28%)	4 / 58 (6.90%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	6 / 45 (13.33%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	1	0	0	7	5	0	0	0	1	6
Haemoglobin decreased
subjects affected / exposed	1 / 1 (100.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	2 / 58 (3.45%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0	1	0	0	1
International normalised ratio increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Lipase increased
subjects affected / exposed	1 / 1 (100.00%)	1 / 10 (10.00%)	2 / 11 (18.18%)	0 / 6 (0.00%)	0 / 11 (0.00%)	2 / 13 (15.38%)	1 / 9 (11.11%)	0 / 11 (0.00%)	3 / 12 (25.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	11 / 57 (19.30%)	13 / 58 (22.41%)	1 / 3 (33.33%)	7 / 36 (19.44%)	0 / 5 (0.00%)	5 / 41 (12.20%)	8 / 45 (17.78%)
occurrences all number	1	1	4	0	0	2	1	0	4	0	1	0	5	16	19	5	10	0	6	9
Liver function test increased
subjects affected / exposed	1 / 1 (100.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Neutrophil count decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	3 / 45 (6.67%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	2	1	0	0	0	1	6
Platelet count decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	2 / 36 (5.56%)	1 / 5 (20.00%)	2 / 41 (4.88%)	5 / 45 (11.11%)
occurrences all number	0	0	0	0	0	0	0	2	0	0	0	0	2	1	1	0	2	1	2	6
Troponin I increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 57 (5.26%)	1 / 58 (1.72%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0	2	0	0	0	3	1	0	1	0	1	0
Transaminases increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	4 / 58 (6.90%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	2	4	0	1	0	0	0
Troponin increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	6 / 57 (10.53%)	5 / 58 (8.62%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	4 / 41 (9.76%)	2 / 45 (4.44%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	6	6	0	1	0	5	2
Urine phosphorus increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Urine calcium increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Weight decreased
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	2 / 11 (18.18%)	0 / 6 (0.00%)	1 / 11 (9.09%)	2 / 13 (15.38%)	2 / 9 (22.22%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 57 (3.51%)	5 / 58 (8.62%)	0 / 3 (0.00%)	8 / 36 (22.22%)	0 / 5 (0.00%)	13 / 41 (31.71%)	5 / 45 (11.11%)
occurrences all number	0	1	2	0	1	2	2	0	1	0	1	0	0	2	5	0	9	0	14	5
White blood cell count decreased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0
White blood cell count increased
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	1 / 6 (16.67%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	1 / 9 (11.11%)	1 / 11 (9.09%)	2 / 12 (16.67%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	1	0	0	1	1	1	2	0	0	0	0	0	1	0	0	0	0	0
Femur fracture
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Infusion related reaction
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	1 / 11 (9.09%)	1 / 6 (16.67%)	1 / 11 (9.09%)	2 / 13 (15.38%)	1 / 9 (11.11%)	2 / 11 (18.18%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	1	1	1	1	2	1	2	0	0	1	0	0	0	0	0	1	0	0	0
Muscle strain
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Lip injury
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Procedural pain
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	1 / 11 (9.09%)	1 / 6 (16.67%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1	1	1	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	1
Rib fracture
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Skin abrasion
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Tooth fracture
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Vascular access site erythema
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Wound secretion
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	1	0
Palpitations
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	2 / 41 (4.88%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	2	0	2	0
Pericardial effusion
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	1	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Sinus bradycardia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Sinus tachycardia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	3 / 41 (7.32%)	3 / 45 (6.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	4	3
Tachycardia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	1 / 36 (2.78%)	1 / 5 (20.00%)	1 / 41 (2.44%)	2 / 45 (4.44%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	1	0	1	1	0	1	1	1	2
Nervous system disorders
Aphasia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	1	0
Cognitive disorder
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0
Dysarthria
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0
Dizziness
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	0 / 11 (0.00%)	1 / 6 (16.67%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	2 / 12 (16.67%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	5 / 57 (8.77%)	2 / 58 (3.45%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	1 / 41 (2.44%)	2 / 45 (4.44%)
occurrences all number	0	1	0	1	0	0	0	0	3	0	1	0	0	5	2	0	1	0	1	3
Headache
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	1 / 11 (9.09%)	3 / 13 (23.08%)	1 / 9 (11.11%)	0 / 11 (0.00%)	1 / 12 (8.33%)	4 / 9 (44.44%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	10 / 57 (17.54%)	10 / 58 (17.24%)	0 / 3 (0.00%)	5 / 36 (13.89%)	2 / 5 (40.00%)	1 / 41 (2.44%)	9 / 45 (20.00%)
occurrences all number	0	0	0	0	1	3	1	0	1	5	1	0	0	11	15	0	5	2	1	10
Dysgeusia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 57 (3.51%)	1 / 58 (1.72%)	0 / 3 (0.00%)	1 / 36 (2.78%)	1 / 5 (20.00%)	2 / 41 (4.88%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0	0	0	2	1	0	1	1	2	1
Hyperaesthesia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Lethargy
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	1 / 6 (16.67%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Neuralgia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	1 / 3 (33.33%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0
Neuropathy peripheral
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	1 / 6 (16.67%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Paraesthesia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 57 (3.51%)	2 / 58 (3.45%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	1	0	0	2	2	0	0	0	0	0
Parkinson's disease
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	1 / 5 (20.00%)	0 / 41 (0.00%)	0 / 45 (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
Peripheral sensory neuropathy
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	2 / 9 (22.22%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	1
Peripheral motor neuropathy
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Post herpetic neuralgia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	1 / 3 (33.33%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Restless legs syndrome
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Radiculopathy
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Somnolence
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Sciatica
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	2	0	0	0	0	0
Tension headache
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	1
Tremor
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 57 (3.51%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	1 / 5 (20.00%)	0 / 41 (0.00%)	2 / 45 (4.44%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	1	2	1	0	0	1	0	2
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 1 (0.00%)	3 / 10 (30.00%)	3 / 11 (27.27%)	1 / 6 (16.67%)	1 / 11 (9.09%)	5 / 13 (38.46%)	3 / 9 (33.33%)	1 / 11 (9.09%)	6 / 12 (50.00%)	1 / 9 (11.11%)	4 / 10 (40.00%)	1 / 3 (33.33%)	2 / 3 (66.67%)	27 / 57 (47.37%)	31 / 58 (53.45%)	2 / 3 (66.67%)	13 / 36 (36.11%)	1 / 5 (20.00%)	21 / 41 (51.22%)	23 / 45 (51.11%)
occurrences all number	0	4	3	1	1	5	4	1	6	1	4	1	3	33	48	2	19	1	35	32
Eosinophilia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	3 / 36 (8.33%)	0 / 5 (0.00%)	1 / 41 (2.44%)	2 / 45 (4.44%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	4	0	2	2
Iron deficiency anaemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Leukocytosis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Lymphopenia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	2	0	0	1
Thrombocytopenia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 57 (3.51%)	1 / 58 (1.72%)	1 / 3 (33.33%)	0 / 36 (0.00%)	1 / 5 (20.00%)	4 / 41 (9.76%)	3 / 45 (6.67%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	2	1	1	0	1	4	3
Neutropenia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	2 / 58 (3.45%)	1 / 3 (33.33%)	2 / 36 (5.56%)	0 / 5 (0.00%)	2 / 41 (4.88%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	2	2	1	2	0	2	2
Ear and labyrinth disorders
Ear pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0
Hypoacusis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0
Vertigo
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 57 (5.26%)	2 / 58 (3.45%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	2 / 45 (4.44%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	3	2	0	1	0	0	2
Eye disorders
Dry eye
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	1	1
Iridocyclitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0
Eyelid irritation
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Vision blurred
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	4 / 58 (6.90%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	1	4	0	0	0	0	1
Swelling of eyelid
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Abdominal distension
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	1 / 12 (8.33%)	2 / 9 (22.22%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	1	0	1	0	0	1	1	2	0	0	0	0	0	0	1	0	0	0
Abdominal pain
subjects affected / exposed	1 / 1 (100.00%)	1 / 10 (10.00%)	1 / 11 (9.09%)	3 / 6 (50.00%)	2 / 11 (18.18%)	3 / 13 (23.08%)	0 / 9 (0.00%)	1 / 11 (9.09%)	5 / 12 (41.67%)	2 / 9 (22.22%)	2 / 10 (20.00%)	1 / 3 (33.33%)	1 / 3 (33.33%)	10 / 57 (17.54%)	3 / 58 (5.17%)	0 / 3 (0.00%)	4 / 36 (11.11%)	0 / 5 (0.00%)	3 / 41 (7.32%)	8 / 45 (17.78%)
occurrences all number	1	1	2	3	2	3	0	1	8	2	2	1	1	12	4	0	4	0	3	8
Abdominal pain lower
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	1 / 6 (16.67%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Abdominal pain upper
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	1 / 6 (16.67%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 57 (3.51%)	2 / 58 (3.45%)	0 / 3 (0.00%)	4 / 36 (11.11%)	1 / 5 (20.00%)	0 / 41 (0.00%)	3 / 45 (6.67%)
occurrences all number	0	0	1	1	0	1	0	0	1	0	1	0	0	2	2	0	4	2	0	5
Ascites
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	1	0	0	1	0	0	1	0	0	0
Colitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	1 / 9 (11.11%)	0 / 11 (0.00%)	1 / 12 (8.33%)	1 / 9 (11.11%)	1 / 10 (10.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	5 / 57 (8.77%)	1 / 58 (1.72%)	0 / 3 (0.00%)	3 / 36 (8.33%)	0 / 5 (0.00%)	2 / 41 (4.88%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	2	0	1	3	2	2	0	7	1	0	4	0	2	0
Constipation
subjects affected / exposed	0 / 1 (0.00%)	2 / 10 (20.00%)	1 / 11 (9.09%)	3 / 6 (50.00%)	5 / 11 (45.45%)	6 / 13 (46.15%)	0 / 9 (0.00%)	2 / 11 (18.18%)	3 / 12 (25.00%)	1 / 9 (11.11%)	1 / 10 (10.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	8 / 57 (14.04%)	9 / 58 (15.52%)	2 / 3 (66.67%)	5 / 36 (13.89%)	1 / 5 (20.00%)	6 / 41 (14.63%)	4 / 45 (8.89%)
occurrences all number	0	2	1	4	6	7	0	2	3	1	1	0	1	9	12	2	6	1	8	4
Diarrhoea
subjects affected / exposed	0 / 1 (0.00%)	7 / 10 (70.00%)	3 / 11 (27.27%)	0 / 6 (0.00%)	1 / 11 (9.09%)	2 / 13 (15.38%)	3 / 9 (33.33%)	1 / 11 (9.09%)	6 / 12 (50.00%)	1 / 9 (11.11%)	4 / 10 (40.00%)	1 / 3 (33.33%)	2 / 3 (66.67%)	25 / 57 (43.86%)	19 / 58 (32.76%)	1 / 3 (33.33%)	15 / 36 (41.67%)	2 / 5 (40.00%)	19 / 41 (46.34%)	19 / 45 (42.22%)
occurrences all number	0	9	5	0	1	3	6	1	12	1	7	2	3	38	27	1	33	4	28	26
Dyspepsia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	2 / 45 (4.44%)
occurrences all number	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	1	0	0	3
Dry mouth
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	1 / 9 (11.11%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	2 / 58 (3.45%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	3 / 41 (7.32%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	1	1	0	0	0	0	0	1	2	0	2	0	3	0
Dysphagia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	2 / 41 (4.88%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	1	0	2	1
Enteritis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Flatulence
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	3 / 58 (5.17%)	0 / 3 (0.00%)	1 / 36 (2.78%)	1 / 5 (20.00%)	1 / 41 (2.44%)	2 / 45 (4.44%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	3	0	1	1	2	2
Frequent bowel movements
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Gastritis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	2 / 10 (20.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	1 / 41 (2.44%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	3	0	0	0	1	0	2	0	1	1
Gastrointestinal motility disorder
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Gastrointestinal haemorrhage
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	1 / 3 (33.33%)	2 / 36 (5.56%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0	0	0	0	0	0	0	1	1	2	0	0	0
Immune-mediated enterocolitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 57 (3.51%)	0 / 58 (0.00%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	2 / 41 (4.88%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	3	0	2	0
Impaired gastric emptying
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Mouth ulceration
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Nausea
subjects affected / exposed	0 / 1 (0.00%)	5 / 10 (50.00%)	3 / 11 (27.27%)	1 / 6 (16.67%)	2 / 11 (18.18%)	4 / 13 (30.77%)	2 / 9 (22.22%)	3 / 11 (27.27%)	6 / 12 (50.00%)	1 / 9 (11.11%)	3 / 10 (30.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	18 / 57 (31.58%)	19 / 58 (32.76%)	0 / 3 (0.00%)	9 / 36 (25.00%)	1 / 5 (20.00%)	12 / 41 (29.27%)	13 / 45 (28.89%)
occurrences all number	0	6	3	1	2	4	2	3	12	1	3	0	2	21	29	0	11	1	13	16
Oesophageal varices haemorrhage
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Oral dysaesthesia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Proctalgia
subjects affected / exposed	0 / 1 (0.00%)	2 / 10 (20.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	2 / 58 (3.45%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	2	0	0	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0
Rectal haemorrhage
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	1	1	0	0	0	0	0
Stomatitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	2 / 36 (5.56%)	1 / 5 (20.00%)	2 / 41 (4.88%)	3 / 45 (6.67%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	1	0	0	1	0	3	1	2	5
Vomiting
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	4 / 11 (36.36%)	1 / 6 (16.67%)	2 / 11 (18.18%)	3 / 13 (23.08%)	1 / 9 (11.11%)	1 / 11 (9.09%)	4 / 12 (33.33%)	0 / 9 (0.00%)	2 / 10 (20.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	12 / 57 (21.05%)	12 / 58 (20.69%)	0 / 3 (0.00%)	7 / 36 (19.44%)	0 / 5 (0.00%)	3 / 41 (7.32%)	11 / 45 (24.44%)
occurrences all number	0	0	5	1	3	5	1	1	6	0	2	0	0	15	14	0	9	0	5	13
Hepatobiliary disorders
Biliary obstruction
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Autoimmune hepatitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0
Hepatitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 57 (7.02%)	2 / 58 (3.45%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	2	0	0	0	0	0	0	0	4	2	0	4	0	0	1
Hepatic failure
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hyperbilirubinaemia
subjects affected / exposed	1 / 1 (100.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	1	0	0	0	0	1	0	0	0	0	1	0	0	1	1	0	0	0	0	0
Hypertransaminasaemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	6 / 57 (10.53%)	1 / 58 (1.72%)	0 / 3 (0.00%)	5 / 36 (13.89%)	0 / 5 (0.00%)	1 / 41 (2.44%)	2 / 45 (4.44%)
occurrences all number	0	0	0	0	0	2	0	0	0	0	0	0	0	6	1	0	5	0	1	2
Immune-mediated hepatitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	4 / 58 (6.90%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0	0	0	0	0	0	6	0	0	0	1	0
Jaundice cholestatic
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Portal hypertension
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	1	0	1	0	1	0	0	0
Acquired porokeratosis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Dermatitis acneiform
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	1	0	0	0
Drug eruption
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	1 / 5 (20.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0
Dry skin
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	2 / 58 (3.45%)	0 / 3 (0.00%)	1 / 36 (2.78%)	1 / 5 (20.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	1	0	0	0	0	1	0	1	0	0	0	0	3	0	1	1	0	0
Eczema
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	3 / 36 (8.33%)	1 / 5 (20.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	4	1	0	0
Erythema
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	4 / 58 (6.90%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	4	0	0	0	1	0
Ecchymosis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Night sweats
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	1 / 6 (16.67%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	0	1	0	2	0	0	0	0	0	0	0	1	1	0	0	0	0	1
Keloid scar
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	1 / 5 (20.00%)	0 / 41 (0.00%)	0 / 45 (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
Leukoplakia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Rash
subjects affected / exposed	1 / 1 (100.00%)	1 / 10 (10.00%)	2 / 11 (18.18%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	3 / 12 (25.00%)	2 / 9 (22.22%)	1 / 10 (10.00%)	1 / 3 (33.33%)	1 / 3 (33.33%)	17 / 57 (29.82%)	18 / 58 (31.03%)	1 / 3 (33.33%)	2 / 36 (5.56%)	0 / 5 (0.00%)	6 / 41 (14.63%)	7 / 45 (15.56%)
occurrences all number	1	1	2	0	0	0	0	0	3	2	1	1	1	21	21	1	2	0	7	8
Pruritus
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	2 / 11 (18.18%)	0 / 6 (0.00%)	1 / 11 (9.09%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	2 / 9 (22.22%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	22 / 57 (38.60%)	25 / 58 (43.10%)	1 / 3 (33.33%)	10 / 36 (27.78%)	1 / 5 (20.00%)	16 / 41 (39.02%)	12 / 45 (26.67%)
occurrences all number	0	1	2	0	1	3	0	0	1	2	0	0	0	28	41	2	11	1	17	16
Palmar-plantar erythrodysaesthesia syndrome
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Rash maculo-papular
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	9 / 57 (15.79%)	11 / 58 (18.97%)	0 / 3 (0.00%)	6 / 36 (16.67%)	2 / 5 (40.00%)	3 / 41 (7.32%)	4 / 45 (8.89%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	1	0	0	9	13	0	7	2	3	4
Rash macular
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	3 / 57 (5.26%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	1 / 45 (2.22%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	1	3	1	0	0	0	2	1
Rash erythematous
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 57 (7.02%)	1 / 58 (1.72%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	4	1	0	1	0	0	0
Rash pruritic
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	1 / 6 (16.67%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Rash vesicular
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Transient acantholytic dermatosis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Skin hypopigmentation
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	2 / 58 (3.45%)	1 / 3 (33.33%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	1	1	0	0	0
Urticaria
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	1	0
Vitiligo
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	7 / 57 (12.28%)	7 / 58 (12.07%)	0 / 3 (0.00%)	4 / 36 (11.11%)	1 / 5 (20.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	7	7	0	4	1	0	0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	1	0	0	0	1	0	0	0	0	0
Pollakiuria
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	0	0	0	1	0	0	0	0	0	0
Proteinuria
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	1	0	0	1	0	0	0	0	1
Haematuria
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	1 / 12 (8.33%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	2 / 57 (3.51%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	2 / 41 (4.88%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	1	1	0	0	1	2	1	0	0	0	2	0
Tubulointerstitial nephritis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0
Endocrine disorders
Adrenal insufficiency
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	1 / 11 (9.09%)	1 / 12 (8.33%)	2 / 9 (22.22%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	6 / 57 (10.53%)	2 / 58 (3.45%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	5 / 41 (12.20%)	2 / 45 (4.44%)
occurrences all number	0	0	0	0	0	0	1	1	2	2	0	0	0	6	2	0	2	0	5	2
Autoimmune thyroiditis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Hyperthyroidism
subjects affected / exposed	0 / 1 (0.00%)	2 / 10 (20.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	2 / 13 (15.38%)	2 / 9 (22.22%)	1 / 11 (9.09%)	0 / 12 (0.00%)	2 / 9 (22.22%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	9 / 57 (15.79%)	12 / 58 (20.69%)	1 / 3 (33.33%)	1 / 36 (2.78%)	1 / 5 (20.00%)	5 / 41 (12.20%)	4 / 45 (8.89%)
occurrences all number	0	2	0	0	0	2	2	1	0	2	1	0	0	10	12	1	1	1	5	4
Hypophysitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	2 / 9 (22.22%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 57 (3.51%)	0 / 58 (0.00%)	0 / 3 (0.00%)	3 / 36 (8.33%)	1 / 5 (20.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	2	1	0	0	2	0	0	3	1	0	0
Hypopituitarism
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	1	0	0	0
Hypothyroidism
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	4 / 13 (30.77%)	0 / 9 (0.00%)	1 / 11 (9.09%)	1 / 12 (8.33%)	2 / 9 (22.22%)	1 / 10 (10.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	13 / 57 (22.81%)	12 / 58 (20.69%)	0 / 3 (0.00%)	8 / 36 (22.22%)	1 / 5 (20.00%)	4 / 41 (9.76%)	8 / 45 (17.78%)
occurrences all number	0	1	1	0	0	4	0	1	1	2	1	1	0	16	13	0	8	1	4	8
Thyroiditis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	4 / 36 (11.11%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	4	0	1	0
Inappropriate antidiuretic hormone secretion
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	2 / 6 (33.33%)	0 / 11 (0.00%)	2 / 13 (15.38%)	1 / 9 (11.11%)	3 / 11 (27.27%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	2 / 3 (66.67%)	15 / 57 (26.32%)	10 / 58 (17.24%)	1 / 3 (33.33%)	5 / 36 (13.89%)	0 / 5 (0.00%)	6 / 41 (14.63%)	12 / 45 (26.67%)
occurrences all number	0	0	1	2	0	3	1	3	1	0	0	0	2	16	15	1	6	0	7	12
Back pain
subjects affected / exposed	0 / 1 (0.00%)	2 / 10 (20.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	3 / 11 (27.27%)	4 / 13 (30.77%)	1 / 9 (11.11%)	1 / 11 (9.09%)	0 / 12 (0.00%)	1 / 9 (11.11%)	2 / 10 (20.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	9 / 57 (15.79%)	6 / 58 (10.34%)	0 / 3 (0.00%)	3 / 36 (8.33%)	0 / 5 (0.00%)	4 / 41 (9.76%)	2 / 45 (4.44%)
occurrences all number	0	2	1	0	3	4	1	1	0	1	2	0	0	9	6	0	3	0	5	2
Groin pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0
Hypercreatinaemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Joint swelling
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	1	0	0	0
Muscular weakness
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	3 / 13 (23.08%)	0 / 9 (0.00%)	1 / 11 (9.09%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	3	0	1	1	0	0	0	0	1	1	0	2	0	0	1
Muscle spasms
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	2 / 11 (18.18%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	4 / 58 (6.90%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	3 / 41 (7.32%)	3 / 45 (6.67%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0	0	0	4	0	1	0	3	3
Musculoskeletal chest pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	0 / 41 (0.00%)	2 / 45 (4.44%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	2	0	0	2
Myalgia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	1 / 11 (9.09%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 57 (7.02%)	5 / 58 (8.62%)	0 / 3 (0.00%)	8 / 36 (22.22%)	0 / 5 (0.00%)	5 / 41 (12.20%)	6 / 45 (13.33%)
occurrences all number	0	0	1	0	1	1	0	0	1	0	0	0	0	4	5	0	9	0	5	8
Myositis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1
Neck pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1
Pain in extremity
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	0 / 11 (0.00%)	1 / 6 (16.67%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 57 (7.02%)	4 / 58 (6.90%)	0 / 3 (0.00%)	3 / 36 (8.33%)	1 / 5 (20.00%)	2 / 41 (4.88%)	2 / 45 (4.44%)
occurrences all number	0	1	0	1	1	0	0	1	0	0	0	0	0	4	6	0	4	1	2	2
Sacral pain
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Infections and infestations
Bronchitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	3 / 41 (7.32%)	2 / 45 (4.44%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	1	0	4	2
Campylobacter infection
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
COVID-19
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	2 / 10 (20.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	4 / 57 (7.02%)	2 / 58 (3.45%)	0 / 3 (0.00%)	7 / 36 (19.44%)	0 / 5 (0.00%)	2 / 41 (4.88%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	3	0	0	4	2	0	7	0	2	1
Candida infection
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Cellulitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	2 / 9 (22.22%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	2 / 45 (4.44%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	1	1	0	1	0	0	2
Conjunctivitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	3 / 36 (8.33%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	1	1	0	4	0	0	0
Cystitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0
Diverticulitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Eye infection bacterial
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Folliculitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Gastroenteritis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 57 (3.51%)	1 / 58 (1.72%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	2	1	0	2	0	0	0
Hepatitis viral
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0
Gastrointestinal infection
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Herpes zoster
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	1 / 3 (33.33%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	1	0	0	0	0
Hordeolum
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0
Influenza
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0
Localised infection
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	1	1	0	1	0	0	0
Mucosal infection
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Nasopharyngitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 57 (3.51%)	2 / 58 (3.45%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	2 / 41 (4.88%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	1	0	0	0	2	2	0	0	0	2	0
Oral candidiasis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	2 / 11 (18.18%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	1 / 58 (1.72%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	0	0	0	0	1	2	0	0	0	0	0	1	1	0	2	0	0	1
Norovirus infection
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Pharyngitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	2 / 58 (3.45%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Rash pustular
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Pneumonia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	2 / 58 (3.45%)	0 / 3 (0.00%)	2 / 36 (5.56%)	0 / 5 (0.00%)	5 / 41 (12.20%)	1 / 45 (2.22%)
occurrences all number	0	0	1	0	0	0	1	0	0	0	0	0	0	0	2	0	2	0	6	1
Soft tissue infection
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	4 / 58 (6.90%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	4	0	0	0	0	0
Skin infection
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	1 / 6 (16.67%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	1 / 3 (33.33%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	1	0	0	0	1	0	0	0	0	0	0	1	1	0	0	0	0
Spontaneous bacterial peritonitis
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (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
Upper respiratory tract infection
subjects affected / exposed	1 / 1 (100.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	1 / 9 (11.11%)	1 / 11 (9.09%)	1 / 12 (8.33%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	1	0	1	0	1	0	3	1	1	1	0	0	0	0	2	0	0	0	0	0
Urinary tract infection
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	2 / 11 (18.18%)	3 / 12 (25.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	6 / 57 (10.53%)	6 / 58 (10.34%)	0 / 3 (0.00%)	3 / 36 (8.33%)	1 / 5 (20.00%)	6 / 41 (14.63%)	8 / 45 (17.78%)
occurrences all number	0	1	1	0	0	0	0	2	3	0	0	0	1	8	7	0	4	2	7	12
Staphylococcal infection
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Vascular access site infection
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Viral infection
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	1 / 5 (20.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	1	0	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	0 / 1 (0.00%)	4 / 10 (40.00%)	3 / 11 (27.27%)	2 / 6 (33.33%)	2 / 11 (18.18%)	4 / 13 (30.77%)	1 / 9 (11.11%)	5 / 11 (45.45%)	3 / 12 (25.00%)	1 / 9 (11.11%)	3 / 10 (30.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	10 / 57 (17.54%)	17 / 58 (29.31%)	0 / 3 (0.00%)	7 / 36 (19.44%)	1 / 5 (20.00%)	16 / 41 (39.02%)	13 / 45 (28.89%)
occurrences all number	0	4	3	2	2	4	1	5	3	2	3	0	0	11	18	0	7	1	16	14
Dehydration
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	3 / 13 (23.08%)	0 / 9 (0.00%)	1 / 11 (9.09%)	4 / 12 (33.33%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	3 / 57 (5.26%)	2 / 58 (3.45%)	0 / 3 (0.00%)	4 / 36 (11.11%)	0 / 5 (0.00%)	1 / 41 (2.44%)	1 / 45 (2.22%)
occurrences all number	0	1	1	0	0	5	0	1	5	0	1	0	0	3	2	0	5	0	1	1
Electrolyte imbalance
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Hyperglycaemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	2 / 11 (18.18%)	2 / 6 (33.33%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	1 / 11 (9.09%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	1 / 3 (33.33%)	5 / 57 (8.77%)	4 / 58 (6.90%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	3 / 41 (7.32%)	5 / 45 (11.11%)
occurrences all number	0	0	2	2	0	0	1	1	0	0	0	0	1	6	5	0	1	0	3	9
Hypercalcaemia
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	1 / 11 (9.09%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	1	1	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	1
Hyperkalaemia
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	2 / 12 (16.67%)	1 / 9 (11.11%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	2 / 58 (3.45%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	3	0	0	1	0	0	0	3	1	1	0	0	1	2	0	0	0	1	0
Hypermagnesaemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hyperlipasaemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	2	0	0	0
Hyperuricaemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	1 / 9 (11.11%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	2 / 57 (3.51%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	2	0	0	0	0	0	0	3	0	0	0	0	1	0
Hypernatraemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	1 / 11 (9.09%)	2 / 6 (33.33%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	1 / 45 (2.22%)
occurrences all number	0	0	1	2	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1
Hypoalbuminaemia
subjects affected / exposed	0 / 1 (0.00%)	1 / 10 (10.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	1 / 11 (9.09%)	2 / 13 (15.38%)	1 / 9 (11.11%)	1 / 11 (9.09%)	5 / 12 (41.67%)	1 / 9 (11.11%)	2 / 10 (20.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	1 / 58 (1.72%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	1 / 41 (2.44%)	1 / 45 (2.22%)
occurrences all number	0	1	1	0	1	2	1	1	5	1	2	0	0	0	1	0	0	0	1	2
Hypocalcaemia
subjects affected / exposed	0 / 1 (0.00%)	2 / 10 (20.00%)	1 / 11 (9.09%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	2 / 12 (16.67%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	2 / 41 (4.88%)	1 / 45 (2.22%)
occurrences all number	0	3	1	0	0	0	0	0	3	0	1	0	0	0	0	0	1	0	3	1
Hypochloraemia
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0
Hypokalaemia
subjects affected / exposed	0 / 1 (0.00%)	3 / 10 (30.00%)	1 / 11 (9.09%)	1 / 6 (16.67%)	3 / 11 (27.27%)	1 / 13 (7.69%)	3 / 9 (33.33%)	0 / 11 (0.00%)	2 / 12 (16.67%)	0 / 9 (0.00%)	2 / 10 (20.00%)	1 / 3 (33.33%)	0 / 3 (0.00%)	1 / 57 (1.75%)	3 / 58 (5.17%)	0 / 3 (0.00%)	1 / 36 (2.78%)	0 / 5 (0.00%)	3 / 41 (7.32%)	1 / 45 (2.22%)
occurrences all number	0	5	1	1	4	2	4	0	4	0	2	1	0	1	7	0	1	0	5	1
Hypomagnesaemia
subjects affected / exposed	1 / 1 (100.00%)	2 / 10 (20.00%)	2 / 11 (18.18%)	0 / 6 (0.00%)	1 / 11 (9.09%)	2 / 13 (15.38%)	0 / 9 (0.00%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	3 / 10 (30.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	1 / 57 (1.75%)	2 / 58 (3.45%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	2 / 41 (4.88%)	3 / 45 (6.67%)
occurrences all number	1	2	2	0	1	2	0	0	1	0	3	0	0	1	3	0	0	0	2	3
Hyponatraemia
subjects affected / exposed	0 / 1 (0.00%)	2 / 10 (20.00%)	2 / 11 (18.18%)	2 / 6 (33.33%)	2 / 11 (18.18%)	0 / 13 (0.00%)	0 / 9 (0.00%)	3 / 11 (27.27%)	3 / 12 (25.00%)	2 / 9 (22.22%)	1 / 10 (10.00%)	1 / 3 (33.33%)	1 / 3 (33.33%)	11 / 57 (19.30%)	16 / 58 (27.59%)	2 / 3 (66.67%)	3 / 36 (8.33%)	1 / 5 (20.00%)	7 / 41 (17.07%)	4 / 45 (8.89%)
occurrences all number	0	2	2	2	2	0	0	6	5	3	1	1	4	19	30	4	4	2	9	5
Hypovolaemia
subjects affected / exposed	1 / 1 (100.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	1 / 11 (9.09%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hypophosphataemia
subjects affected / exposed	0 / 1 (0.00%)	2 / 10 (20.00%)	1 / 11 (9.09%)	2 / 6 (33.33%)	0 / 11 (0.00%)	1 / 13 (7.69%)	1 / 9 (11.11%)	0 / 11 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	1 / 36 (2.78%)	1 / 5 (20.00%)	1 / 41 (2.44%)	0 / 45 (0.00%)
occurrences all number	0	3	1	2	0	1	1	0	1	0	0	0	0	0	0	0	1	1	1	0
Iron deficiency
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	1 / 13 (7.69%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 10 (10.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Malnutrition
subjects affected / exposed	0 / 1 (0.00%)	0 / 10 (0.00%)	0 / 11 (0.00%)	0 / 6 (0.00%)	0 / 11 (0.00%)	0 / 13 (0.00%)	0 / 9 (0.00%)	0 / 11 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 10 (0.00%)	0 / 3 (0.00%)	0 / 3 (0.00%)	0 / 57 (0.00%)	0 / 58 (0.00%)	0 / 3 (0.00%)	0 / 36 (0.00%)	0 / 5 (0.00%)	0 / 41 (0.00%)	0 / 45 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0

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Were there any global substantial amendments to the protocol? Yes

20 Nov 2017

Includes responses to FDA questions about bladder and breast cancer population inclusion criteria, DLT criteria including ocular events, discontinuation from study treatment, clarification of expression of some tumor markers, updated imaging, biopsy and infusion time language.

24 Jan 2018

Expand Part 1B tumor types, clarify the change in frequency of scans up to Week 48 versus thereafter, add co-administration of BMS-986249 + nivolumab in Part 1B, update 2 year treatment duration, add PCWG3 for prostate cancer, and minor typographical updates were made for consistency and clarity of the words participants, patients, and subjects.

25 May 2018

Change dose-limiting toxicity evaluation period, change Parts 1A and 1B treatment assignments, provide a window for clinic visits, incorporate Administrative Letter 01, and minor typographical updates were made for consistency and clarity.

01 Mar 2019

This is a revised protocol to define the Part 2A Expansion Phase, which includes concurrent evaluation of three different dose regimens of BMS- 986249 in combination with nivolumab in relation to two standard of care reference arms in a randomized setting in melanoma. This protocol revision also updates DLT criteria, updates inclusion/exclusion criteria, changes the on-treatment biopsy timing, and provides clarifications around planned dose level modifications/intermediate dose levels, and incorporates other clarifying modifications.

01 May 2019

This is a revised protocol to explicitly mention encephalitis as an example of a possible neurological adverse event, updates management algorithms for immuno-oncology agents, updates PD-L1 stratification criteria for Part 2A, clarifies screening biopsy criteria for Part 2A, and incorporates other clarifying modifications.

05 Aug 2019

This is a revised protocol that defines the selected BMS-986249 + nivolumab doses and schedules for Part 2A Arms A - C, updates modified intermediate dose levels in Part 1B, and incorporates other minor clarifying edits.

15 Nov 2020

This is a revised protocol to modify the treatment arms in the Part 2A Expansion Phase and define the Part 2B Expansion Phase. The Part 2A Expansion Phase will now include concurrent evaluation of 3 treatment arms in a randomized setting in melanoma (2 different dose regimens of BMS- 986249 in combination with nivolumab and 1 standard-of-care reference arm) rather than the previously defined 5 treatment arms. The Part 2B Expansion Phase will evaluate a single-dose regimen of BMS-986248 in combination with nivolumab in 3 tumor-specific cohorts. This revision also includes global changes to reduce redundancies and increase readability, incorporates updated learnings for BMS-986249, nivolumab, and ipilimumab, and adds language around COVID-19.

22 Feb 2022

The primary reasons for Protocol Amendment 08 are to update and/or clarify the inclusion criteria to align with the current disease state and treatment landscape based on investigator feedback for Part 2.

14 Mar 2023

The overall rationale for this protocol amendment is to remove exploratory endpoints (modified RECIST version 1.1 for immune-based therapeutics [iRECIST] and severe acute respiratory syndrome coronavirus 2 [SARSCoV- 2]); to introduce the option of also supplying sites with 10-mL vials containing 50 mg of ipilimumab; to decrease participant and site burden by reducing pharmacokinetic (PK), anti-drug antibody (ADA), and biomarker sample collections; and to add clarifying language.

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.

None reported

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Clinical trials

Clinical Trial Results: A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part 1 A and 1 B

Primary: Number of participants with Adverse Events (AEs) and Serious Adverse Events (SAEs) - Part 1 A and 1 B

Primary: Number of participants with Adverse Events (AEs) meeting Protocol-Defined Dose-Limiting Toxicity (DLT) Criteria - Part 1 A and 1 B

Primary: Number of participants with Adverse Events (AEs) meeting Protocol-Defined Dose-Limiting Toxicity (DLT) Criteria - Part 1 A and 1 B

Primary: Number of Participants who Died – Part 1 A and 1 B

Primary: Number of Participants who Died – Part 1 A and 1 B

Primary: Number of Participants with Shifts from Baseline in Laboratory Test results – Part 1 A and 1 B

Primary: Number of Participants with Shifts from Baseline in Laboratory Test results – Part 1 A and 1 B

Primary: Number of Participants with Treatment-Related Grade 3-5 Adverse Events (AEs) Within 24 weeks – Part 2 A Arms C, D and F, and Part 2 B

Primary: Number of Participants with Treatment-Related Grade 3-5 Adverse Events (AEs) Within 24 weeks – Part 2 A Arms C, D and F, and Part 2 B

Primary: Objective Response Rate (ORR) as Assessed by Investigator - Part 2 A Arm C and F

Primary: Objective Response Rate (ORR) as Assessed by Investigator - Part 2 A Arm C and F

Secondary: Time to Deterioration in Part 2A (Arm C, D and F)

Secondary: Time to Deterioration in Part 2A (Arm C, D and F)

Secondary: Safety Related Events in Part 2A (Arm C, D and F) and 2B

Secondary: Safety Related Events in Part 2A (Arm C, D and F) and 2B

Secondary: BOR of PSA and PCWG3 Response Rate in Part 2B Cohort 2

Secondary: BOR of PSA and PCWG3 Response Rate in Part 2B Cohort 2

Secondary: Progression Free Survival

Secondary: Progression Free Survival

Secondary: Duration of Response

Secondary: Duration of Response

Secondary: Time to Response

Secondary: Time to Response

Secondary: ORR by Investigator

Secondary: ORR by Investigator

Secondary: Objective Response Rate (ORR) as Assessed by Investigator - Part 1 A, 1B, 2A (Arms C,D,F) and 2B

Secondary: Objective Response Rate (ORR) as Assessed by Investigator - Part 1 A, 1B, 2A (Arms C,D,F) and 2B

Secondary: Cmax and Ctau of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B

Secondary: Cmax and Ctau of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B

Secondary: AUC(0-T) and AUC(TAU) of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B

Secondary: AUC(0-T) and AUC(TAU) of BMS-986249 - Part 1 A and B, Part 2 A Arms C and F, Part 2 B

Secondary: Accumulation Index for Cmax (AI_Cmax) and Accumulation Index for AUC (AI_AUC) of BMS-986249 - Part 1 A and B, Part 2 A Arms C, D and F, Part 2 B

Secondary: Accumulation Index for Cmax (AI_Cmax) and Accumulation Index for AUC (AI_AUC) of BMS-986249 - Part 1 A and B, Part 2 A Arms C, D and F, Part 2 B

Secondary: Number of Participants with Shifts from Baseline in Laboratory Test results – Part 2A (Arms C and F) and 2B

Secondary: Number of Participants with Shifts from Baseline in Laboratory Test results – Part 2A (Arms C and F) and 2B

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase 1/2 First-in-Human Study of BMS-986249 Alone and in Combination with Nivolumab in Advanced Solid Tumors