Download PDF

Clinical Trial Results:
Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination with Nivolumab in Advanced Solid Tumors

Summary
EudraCT number	2017-000597-11
Trial protocol	ES DE BE NO NL PL FI RO
Global end of trial date	04 Apr 2024

Results information
Results version number	v1(current)
This version publication date	17 Apr 2025
First version publication date	17 Apr 2025
Other versions

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

Collapse all Expand all

Trial information

Top of page

Sponsor protocol code

CA022-001

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Bristol-Myers Squibb

Sponsor organisation address

Chaussee de la Hulpe 185, Brussels, Belgium, 1170

Public contact

EU Study Start-Up Unit, Bristol-Myers Squibb International Corporation, Clinical.Trials@bms.com

Scientific contact

Bristol-Myers Squibb Study Director, Bristol-Myers Squibb, Clinical.Trials@bms.com

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

08 May 2024

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

04 Apr 2024

Was the trial ended prematurely?

Yes

Main objective of the trial

To characterize the safety, tolerability, and DLTs and to determine the MTD/RP2D of BMS-986218 administered as monotherapy and in combination with nivolumab in participants with advanced solid tumors - To evaluate the efficacy and safety of BMS-986218 monotherapy relative to ipilimumab in participants with advanced cutaneous melanoma previously treated with anti-PD-1/PD-L1 immunotherapy(Part 2A only) - To evaluate the efficacy and safety of BMS-986218 alone and in combination with nivolumab in NSCLC (Part2B and Part 2C) - To evaluate the efficacy and safety of BMS-986218 alone and in combination with nivolumab in MSS CRC (Part 2D)

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 participants were followed.

Background therapy

Evidence for comparator

Actual start date of recruitment

04 May 2017

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Argentina: 32

Country: Number of subjects enrolled

Australia: 8

Country: Number of subjects enrolled

Belgium: 5

Country: Number of subjects enrolled

Canada: 19

Country: Number of subjects enrolled

Chile: 36

Country: Number of subjects enrolled

Finland: 9

Country: Number of subjects enrolled

Germany: 5

Country: Number of subjects enrolled

Israel: 8

Country: Number of subjects enrolled

Italy: 24

Country: Number of subjects enrolled

Netherlands: 12

Country: Number of subjects enrolled

Norway: 8

Country: Number of subjects enrolled

Poland: 1

Country: Number of subjects enrolled

Romania: 12

Country: Number of subjects enrolled

Spain: 56

Country: Number of subjects enrolled

Switzerland: 8

Country: Number of subjects enrolled

United States: 133

Worldwide total number of subjects

376

EEA total number of subjects

132

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)

216

From 65 to 84 years

158

85 years and over

Subject disposition

Top of page

Recruitment details

Screening details

Part 1, Part 2C and Part 2D were non-randomized. Part 2A and Part 2B were randomized.

Period 1 title

Pre-treatment Period

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Part 1A: BMS-986218 2 mg

Arm description

Participants received BMS-986218 at 2 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

2 mg Q4W

Part 1A: BMS-986218 4 mg

Arm description

Participants received BMS-986218 at 4 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

4 mg Q4W

Part 1A: BMS-986218 7 mg

Arm description

Participants received BMS-986218 at 7 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

7 mg Q4W

Part 1A: BMS-986218 20 mg

Arm description

Participants received BMS-986218 at 20 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg Q4W

Part 1A: BMS-986218 40 mg

Arm description

Participants received BMS-986218 at 40 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

40 mg Q4W

Part 1A: BMS-986218 70 mg

Arm description

Participants received BMS-986218 at 70 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

70 mg Q4W

Part 1A: BMS-986218 100 mg

Arm description

Participants received BMS-986218 at 100 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

100 mg Q4W

Part 1A: BMS-986218 150 mg

Arm description

Participants received BMS-986218 at 150 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

150 mg Q4W

Part 1A: BMS-986218 200 mg

Arm description

Participants received BMS-986218 at 200 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

200 mg Q4W

Part 1A: BMS-986218 20 mg

Arm description

Participants received BMS-986218 at 20 mg every 2 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg Q2W

Part 1A: BMS-986218 35 mg

Arm description

Participants received BMS-986218 at 35 mg every 2 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

35 mg Q2W

Part 1A: BMS-986218 50 mg

Arm description

Participants received BMS-986218 at 50 mg every 2 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

50 mg Q2W

Part 1A: BMS-986218 20 mg PD

Arm description

Participants received BMS-986218 at 20 mg every 2 weeks

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg Q2W

Part 1B: BMS-986218 7 mg + Nivo 480 mg

Arm description

Participants received BMS-986218 at 7 mg with nivolumab at 480 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

480 mg Q4W

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

7 mg Q4W

Part 1B: BMS-986218 20 mg + Nivo 480 mg

Arm description

Participants received BMS-986218 at 20 mg with nivolumab at 480 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg Q4W

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

480 mg Q4W

Part 1B: BMS-986218 40 mg + Nivo 480 mg

Arm description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

480 mg Q4W

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

40 mg Q4W

Part 1B: BMS-986218 70 mg + Nivo 480 mg

Arm description

Participants received BMS-986218 at 70 mg with nivolumab at 480 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

480 mg Q4W

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

70 mg Q4W

Part 2A: Ipilimumab Cutaneous Melanoma

Arm description

Participants received ipilimumab at 3 mg/kg every 3 weeks

Arm type

Active comparator

Investigational medicinal product name

Ipilimumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

3 mg/kg Q3W

Part 2A: BMS-986218 7 mg Cutaneous Melanoma

Arm description

Participants received BMS-986218 at 7 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

7 mg Q4W

Part 2A: BMS-986218 20 mg Cutaneous Melanoma

Arm description

Participants received BMS-986218 at 20 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg Q4W

Part 2A: BMS-986218 70 mg Cutaneous Melanoma

Arm description

Participants received BMS-986218 at 70 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

70 mg Q4W

Part 2B: BMS-986218 7 mg NSCLC

Arm description

Participants received BMS-986218 at 7 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

7 mg Q4W

Part 2B: BMS-986218 20 mg NSCLC

Arm description

Participants received BMS-986218 at 20 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg Q4W

Part 2B: BMS-986218 70 mg NSCLC

Arm description

Participants received BMS-986218 at 70 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

70 mg Q4W

Part 2C: BMS-986218 + Nivo NSCLC

Arm description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

480 mg Q4W

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

40 mg Q4W

Part 2D: BMS-986218 + Nivo MSS CRC

Arm description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

480 mg Q4W

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

40 mg Q4W

Number of subjects in period 1	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Started	4	9	12	15	12	14	7	11	5	14	6	4	1	5	17	19	7	20	19	18	18	22	22	22	29	44
Completed	4	9	12	15	12	14	7	11	5	14	6	4	1	5	17	19	7	20	19	18	18	22	22	22	29	44

Period 2 title

Treatment Period

Is this the baseline period?

Allocation method

Randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Part 1A: BMS-986218 2 mg

Arm description

Participants received BMS-986218 at 2 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

2 mg Q4W

Part 1A: BMS-986218 4 mg

Arm description

Participants received BMS-986218 at 4 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

4 mg Q4W

Part 1A: BMS-986218 7 mg

Arm description

Participants received BMS-986218 at 7 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

7 mg Q4W

Part 1A: BMS-986218 20 mg

Arm description

Participants received BMS-986218 at 20 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg Q4W

Part 1A: BMS-986218 40 mg

Arm description

Participants received BMS-986218 at 40 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

40 mg Q4W

Part 1A: BMS-986218 70 mg

Arm description

Participants received BMS-986218 at 70 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

70 mg Q4W

Part 1A: BMS-986218 100 mg

Arm description

Participants received BMS-986218 at 100 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

100 mg Q4W

Part 1A: BMS-986218 150 mg

Arm description

Participants received BMS-986218 at 150 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

150 mg Q4W

Part 1A: BMS-986218 200 mg

Arm description

Participants received BMS-986218 at 200 mg every 4 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

200 mg Q4W

Part 1A: BMS-986218 20 mg

Arm description

Participants received BMS-986218 at 20 mg every 2 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg Q2W

Part 1A: BMS-986218 35 mg

Arm description

Participants received BMS-986218 at 35 mg every 2 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

35 mg Q2W

Part 1A: BMS-986218 50 mg

Arm description

Participants received BMS-986218 at 50 mg every 2 weeks for up to 2 years

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

50 mg Q2W

Part 1A: BMS-986218 20 mg PD

Arm description

Participants received BMS-986218 at 20 mg every 2 weeks

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg Q2W

Part 1B: BMS-986218 7 mg + Nivo 480 mg

Arm description

Participants received BMS-986218 at 7 mg with nivolumab at 480 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

480 mg Q4W

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

7 mg Q4W

Part 1B: BMS-986218 20 mg + Nivo 480 mg

Arm description

Participants received BMS-986218 at 20 mg with nivolumab at 480 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

480 mg Q4W

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg Q4W

Part 1B: BMS-986218 40 mg + Nivo 480 mg

Arm description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

480 mg Q4W

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

40 mg Q4W

Part 1B: BMS-986218 70 mg + Nivo 480 mg

Arm description

Participants received BMS-986218 at 70 mg with nivolumab at 480 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

480 mg Q4W

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

70 mg Q4W

Part 2A: Ipilimumab Cutaneous Melanoma

Arm description

Participants received ipilimumab at 3 mg/kg every 3 weeks

Arm type

Active comparator

Investigational medicinal product name

Ipilimumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

3 mg/kg Q3W

Part 2A: BMS-986218 7 mg Cutaneous Melanoma

Arm description

Participants received BMS-986218 at 7 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

7 mg Q4W

Part 2A: BMS-986218 20 mg Cutaneous Melanoma

Arm description

Participants received BMS-986218 at 20 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg Q4W

Part 2A: BMS-986218 70 mg Cutaneous Melanoma

Arm description

Participants received BMS-986218 at 70 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

70 mg Q4W

Part 2B: BMS-986218 7 mg NSCLC

Arm description

Participants received BMS-986218 at 7 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

7 mg Q4W

Part 2B: BMS-986218 20 mg NSCLC

Arm description

Participants received BMS-986218 at 20 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

20 mg Q4W

Part 2B: BMS-986218 70 mg NSCLC

Arm description

Participants received BMS-986218 at 70 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

70 mg Q4W

Part 2C: BMS-986218 + Nivo NSCLC

Arm description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

480 mg Q4W

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

40 mg Q4W

Part 2D: BMS-986218 + Nivo MSS CRC

Arm description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

480 mg Q4W

Investigational medicinal product name

BMS-986218

Investigational medicinal product code

Other name

Pharmaceutical forms

Concentrate for solution for injection

Routes of administration

Intravenous use

Dosage and administration details

40 mg Q4W

Number of subjects in period 2	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Started	4	9	12	15	12	14	7	11	5	14	6	4	1	5	17	19	7	20	19	18	18	22	22	22	29	44
Completed	0	0	0	1	0	1	0	0	0	0	0	0	0	0	1	0	0	13	0	0	0	2	0	0	0	1
Not completed	4	9	12	14	12	13	7	11	5	14	6	4	1	5	16	19	7	7	19	18	18	20	22	22	29	43
Adverse event, serious fatal	-	-	-	-	-	-	-	-	-	-	-	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-
Participant withdrew consent	-	-	1	-	4	3	-	-	-	1	-	-	-	-	-	-	-	-	-	1	-	2	-	-	-	2
Study drug toxicity	1	-	1	2	-	3	1	1	3	2	-	2	-	-	2	3	3	3	1	2	2	-	2	6	7	6
Adverse event, non-fatal	-	-	1	-	-	2	-	2	-	1	-	-	-	-	-	2	-	1	2	1	4	2	2	2	2	4
Other Reasons	-	-	1	1	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-
Participants no longer meets study criteria	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	-	1	-	-
Disease Progression	3	9	8	11	8	4	6	7	2	10	5	2	-	5	14	14	4	3	16	14	12	16	18	13	16	31
Participant request to discontinue study treatment	-	-	-	-	-	-	-	1	-	-	1	-	-	-	-	-	-	-	-	-	-	-	-	-	3	-

Baseline characteristics

Top of page

Reporting group title

Part 1A: BMS-986218 2 mg

Reporting group description

Participants received BMS-986218 at 2 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 4 mg

Reporting group description

Participants received BMS-986218 at 4 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 7 mg

Reporting group description

Participants received BMS-986218 at 7 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 20 mg

Reporting group description

Participants received BMS-986218 at 20 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 40 mg

Reporting group description

Participants received BMS-986218 at 40 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 70 mg

Reporting group description

Participants received BMS-986218 at 70 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 100 mg

Reporting group description

Participants received BMS-986218 at 100 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 150 mg

Reporting group description

Participants received BMS-986218 at 150 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 200 mg

Reporting group description

Participants received BMS-986218 at 200 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 20 mg

Reporting group description

Participants received BMS-986218 at 20 mg every 2 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 35 mg

Reporting group description

Participants received BMS-986218 at 35 mg every 2 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 50 mg

Reporting group description

Participants received BMS-986218 at 50 mg every 2 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 20 mg PD

Reporting group description

Participants received BMS-986218 at 20 mg every 2 weeks

Reporting group title

Part 1B: BMS-986218 7 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 7 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 1B: BMS-986218 20 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 20 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 1B: BMS-986218 40 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 1B: BMS-986218 70 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 70 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 2A: Ipilimumab Cutaneous Melanoma

Reporting group description

Participants received ipilimumab at 3 mg/kg every 3 weeks

Reporting group title

Part 2A: BMS-986218 7 mg Cutaneous Melanoma

Reporting group description

Participants received BMS-986218 at 7 mg every 4 weeks

Reporting group title

Part 2A: BMS-986218 20 mg Cutaneous Melanoma

Reporting group description

Participants received BMS-986218 at 20 mg every 4 weeks

Reporting group title

Part 2A: BMS-986218 70 mg Cutaneous Melanoma

Reporting group description

Participants received BMS-986218 at 70 mg every 4 weeks

Reporting group title

Part 2B: BMS-986218 7 mg NSCLC

Reporting group description

Participants received BMS-986218 at 7 mg every 4 weeks

Reporting group title

Part 2B: BMS-986218 20 mg NSCLC

Reporting group description

Participants received BMS-986218 at 20 mg every 4 weeks

Reporting group title

Part 2B: BMS-986218 70 mg NSCLC

Reporting group description

Participants received BMS-986218 at 70 mg every 4 weeks

Reporting group title

Part 2C: BMS-986218 + Nivo NSCLC

Reporting group description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 2D: BMS-986218 + Nivo MSS CRC

Reporting group description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Reporting group values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC	Total
Number of subjects	4	9	12	15	12	14	7	11	5	14	6	4	1	5	17	19	7	20	19	18	18	22	22	22	29	44	376
Age categorical
Units: Subjects
Adults (18-64 years)	3	5	7	9	7	13	5	5	4	10	3	4	0	0	13	12	5	10	9	7	9	9	6	11	17	33	216
From 65-84 years	1	4	4	6	5	1	2	6	1	4	3	0	1	5	4	7	2	10	10	10	9	13	16	11	12	11	158
85 years and over	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	2
Age Continuous
Units: Years
arithmetic mean (standard deviation)	49.5 ( 23.1 )	63.6 ( 11.4 )	65.6 ( 11.1 )	63.3 ( 8.3 )	60.6 ( 12.1 )	55.1 ( 9.5 )	58.7 ( 6.1 )	65.5 ( 10.1 )	57.8 ( 10.2 )	60.1 ( 12.2 )	64.7 ( 6.7 )	54.5 ( 4.1 )	76.0 ( 0 )	70.4 ( 6.1 )	58.7 ( 11.3 )	61.1 ( 9.5 )	57.7 ( 9.7 )	65.6 ( 11.6 )	61.8 ( 14.4 )	65.8 ( 14.6 )	64.6 ( 13.2 )	66.0 ( 8.6 )	65.9 ( 11.2 )	62.8 ( 7.4 )	62.7 ( 9.8 )	55.3 ( 11.5 )	-
Sex: Female, Male
Units: Participants
Female	2	3	4	6	7	8	5	7	2	9	0	3	0	2	5	8	7	10	9	11	4	10	7	6	16	24	175
Male	2	6	8	9	5	6	2	4	3	5	6	1	1	3	12	11	0	10	10	7	14	12	15	16	13	20	201
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2
Asian	0	0	1	0	0	1	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	1	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	0	0	0	0	0	0
Black or African American	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	4
White	3	9	9	15	10	9	7	10	4	13	6	4	0	5	13	18	6	20	19	18	18	22	21	21	29	42	351
More than one race	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	1	0	2	0	0	4	0	0	1	0	0	0	1	0	3	0	1	0	0	0	0	0	0	0	0	1	14
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	1	3	2	1	0	2	0	0	0	1	0	0	1	0	1	0	0	4	7	5	0	5	3	1	1	1	39
Not Hispanic or Latino	3	6	10	11	11	12	5	8	4	10	4	2	0	3	12	6	3	7	5	5	3	8	13	5	10	11	177
Unknown or Not Reported	0	0	0	3	1	0	2	3	1	3	2	2	0	2	4	13	4	9	7	8	15	9	6	16	18	32	160

End points

Top of page

Reporting group title

Part 1A: BMS-986218 2 mg

Reporting group description

Participants received BMS-986218 at 2 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 4 mg

Reporting group description

Participants received BMS-986218 at 4 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 7 mg

Reporting group description

Participants received BMS-986218 at 7 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 20 mg

Reporting group description

Participants received BMS-986218 at 20 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 40 mg

Reporting group description

Participants received BMS-986218 at 40 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 70 mg

Reporting group description

Participants received BMS-986218 at 70 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 100 mg

Reporting group description

Participants received BMS-986218 at 100 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 150 mg

Reporting group description

Participants received BMS-986218 at 150 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 200 mg

Reporting group description

Participants received BMS-986218 at 200 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 20 mg

Reporting group description

Participants received BMS-986218 at 20 mg every 2 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 35 mg

Reporting group description

Participants received BMS-986218 at 35 mg every 2 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 50 mg

Reporting group description

Participants received BMS-986218 at 50 mg every 2 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 20 mg PD

Reporting group description

Participants received BMS-986218 at 20 mg every 2 weeks

Reporting group title

Part 1B: BMS-986218 7 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 7 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 1B: BMS-986218 20 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 20 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 1B: BMS-986218 40 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 1B: BMS-986218 70 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 70 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 2A: Ipilimumab Cutaneous Melanoma

Reporting group description

Participants received ipilimumab at 3 mg/kg every 3 weeks

Reporting group title

Part 2A: BMS-986218 7 mg Cutaneous Melanoma

Reporting group description

Participants received BMS-986218 at 7 mg every 4 weeks

Reporting group title

Part 2A: BMS-986218 20 mg Cutaneous Melanoma

Reporting group description

Participants received BMS-986218 at 20 mg every 4 weeks

Reporting group title

Part 2A: BMS-986218 70 mg Cutaneous Melanoma

Reporting group description

Participants received BMS-986218 at 70 mg every 4 weeks

Reporting group title

Part 2B: BMS-986218 7 mg NSCLC

Reporting group description

Participants received BMS-986218 at 7 mg every 4 weeks

Reporting group title

Part 2B: BMS-986218 20 mg NSCLC

Reporting group description

Participants received BMS-986218 at 20 mg every 4 weeks

Reporting group title

Part 2B: BMS-986218 70 mg NSCLC

Reporting group description

Participants received BMS-986218 at 70 mg every 4 weeks

Reporting group title

Part 2C: BMS-986218 + Nivo NSCLC

Reporting group description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 2D: BMS-986218 + Nivo MSS CRC

Reporting group description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 1A: BMS-986218 2 mg

Reporting group description

Participants received BMS-986218 at 2 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 4 mg

Reporting group description

Participants received BMS-986218 at 4 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 7 mg

Reporting group description

Participants received BMS-986218 at 7 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 20 mg

Reporting group description

Participants received BMS-986218 at 20 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 40 mg

Reporting group description

Participants received BMS-986218 at 40 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 70 mg

Reporting group description

Participants received BMS-986218 at 70 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 100 mg

Reporting group description

Participants received BMS-986218 at 100 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 150 mg

Reporting group description

Participants received BMS-986218 at 150 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 200 mg

Reporting group description

Participants received BMS-986218 at 200 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 20 mg

Reporting group description

Participants received BMS-986218 at 20 mg every 2 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 35 mg

Reporting group description

Participants received BMS-986218 at 35 mg every 2 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 50 mg

Reporting group description

Participants received BMS-986218 at 50 mg every 2 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 20 mg PD

Reporting group description

Participants received BMS-986218 at 20 mg every 2 weeks

Reporting group title

Part 1B: BMS-986218 7 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 7 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 1B: BMS-986218 20 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 20 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 1B: BMS-986218 40 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 1B: BMS-986218 70 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 70 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 2A: Ipilimumab Cutaneous Melanoma

Reporting group description

Participants received ipilimumab at 3 mg/kg every 3 weeks

Reporting group title

Part 2A: BMS-986218 7 mg Cutaneous Melanoma

Reporting group description

Participants received BMS-986218 at 7 mg every 4 weeks

Reporting group title

Part 2A: BMS-986218 20 mg Cutaneous Melanoma

Reporting group description

Participants received BMS-986218 at 20 mg every 4 weeks

Reporting group title

Part 2A: BMS-986218 70 mg Cutaneous Melanoma

Reporting group description

Participants received BMS-986218 at 70 mg every 4 weeks

Reporting group title

Part 2B: BMS-986218 7 mg NSCLC

Reporting group description

Participants received BMS-986218 at 7 mg every 4 weeks

Reporting group title

Part 2B: BMS-986218 20 mg NSCLC

Reporting group description

Participants received BMS-986218 at 20 mg every 4 weeks

Reporting group title

Part 2B: BMS-986218 70 mg NSCLC

Reporting group description

Participants received BMS-986218 at 70 mg every 4 weeks

Reporting group title

Part 2C: BMS-986218 + Nivo NSCLC

Reporting group description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 2D: BMS-986218 + Nivo MSS CRC

Reporting group description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Primary: Number of Participants with Adverse Events (AEs)

Top of page

End point title

Number of Participants with Adverse Events (AEs) ^[1]

End point description

An Adverse Event (AE) is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

End point type

Primary

End point timeframe

From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Qualitative statistics were planned for this endpoint only

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	4	9	12	15	12	14	7	11	5	14	6	4	1	5	17	19	7	20	19	18	18	22	22	22	29	44
Units: Participants	4	9	11	15	12	14	7	11	5	13	6	4	1	5	17	19	7	18	19	15	17	21	22	22	29	44

No statistical analyses for this end point

Primary: Number of Participants with Serious Adverse Events (SAEs)

Top of page

End point title

Number of Participants with Serious Adverse Events (SAEs) ^[2]

End point description

Serious Adverse Event (SAE) is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, and requires inpatient hospitalization or causes prolongation of existing hospitalization.

End point type

Primary

End point timeframe

From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)

Notes
[2] - 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: Qualitative statistics were planned for this endpoint only

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	4	9	12	15	12	14	7	11	5	14	6	4	1	5	17	19	7	20	19	18	18	22	22	22	29	44
Units: Participants	2	5	5	9	10	7	5	7	5	10	4	3	1	3	13	18	7	9	11	12	12	16	15	17	23	34

No statistical analyses for this end point

Primary: Number of Participants with Adverse Events (AEs) meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria

Top of page

End point title

Number of Participants with Adverse Events (AEs) meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria ^[3]

End point description

Dose-Limiting Toxicities (DLTs) are effects of a treatment that are serious enough to prevent an increase in dose of that treatment. Grade 1=Mild, 2=Moderate, 3=Severe, 4=Life-threatening, 5=Death Gastrointestinal DLT: • Grade 2 colitis >5 days • Grade ≥3 diarrhea/colitis Hepatic DLT: • Grade 4 serum transaminases (AST & ALT), alkaline phosphatase (ALP), or total bilirubin elevations • Grade 3 serum AST, ALT, or ALP elevations lasting >5 days or with clinical symptoms or bilirubin > 2×ULN without cholestasis Hematologic DLT: • Grade 4 neutropenia ≥7 days • Grade 4 thrombocytopenia Dermatologic DLT: • Grade 4 rash • Grade 3 rash if no improvement after 1–2-week infusion delay Other DLTs: • Grade 2 drug-related uveitis, episcleritis, iritis, eye pain, or blurred vision that doesn’t respond to treatment, doesn’t improve within the re-treatment period OR requires systemic treatment • Grade 3 drug-related uveitis, episcleritis, iritis, pneumonitis, bronchospasm, or neurologic toxicity

End point type

Primary

End point timeframe

From first dose of study medication through 60 days following last dose of study treatment (assessed for an average of 7 months up to a max of approximately 27 months)

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Qualitative statistics were planned for this endpoint only

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	4	9	11	13	10	12	7	11	5	14	5	4	1	5	14	16	7	3	3	2	2	6	7	4	18	18
Units: Participants	1	0	0	1	0	2	0	0	2	0	0	0	0	0	1	2	3	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Primary: Number of Participants with Adverse Events (AEs) Leading to Discontinuation

Top of page

End point title

Number of Participants with Adverse Events (AEs) Leading to Discontinuation ^[4]

End point description

End point type

Primary

End point timeframe

From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)

Notes
[4] - 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: Qualitative statistics were planned for this endpoint only

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	4	9	12	15	12	14	7	11	5	14	6	4	1	5	17	19	7	20	19	18	18	22	22	22	29	44
Units: Participants	1	0	1	2	0	3	1	1	3	2	0	2	0	0	2	3	3	3	1	2	2	0	2	6	7	6

No statistical analyses for this end point

Primary: Number of Participants Who Died

Top of page

End point title

Number of Participants Who Died ^[5]

End point description

Number of participants who died during the study

End point type

Primary

End point timeframe

From randomization (Part 2A and 2B) or first dose (Part 1, 2C and 2D) until study closure (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: Qualitative statistics were planned for this endpoint only

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	4	9	12	15	12	14	7	11	5	14	6	4	1	5	17	19	7	20	19	18	18	22	22	22	29	44
Units: Participants	2	7	6	10	8	7	6	10	1	10	6	3	0	4	15	14	5	13	16	16	18	19	20	16	28	37

No statistical analyses for this end point

Primary: Objective Response Rate (ORR) for Part 2 only

Top of page

End point title

Objective Response Rate (ORR) for Part 2 only ^[6] ^[7]

End point description

End point type

Primary

End point timeframe

From the start of the study treatment until disease progression, or the last response recorded, taking into account any requirement for confirmation and censoring rules regarding subsequent therapy (Up to approximately 83 months)

Notes
[6] - 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: Qualitative statistics were planned for this endpoint only
[7] - 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: Pre-specified to be reported for Part 2 only

End point values	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	20	19	18	18	22	22	22	29	44
Units: Percent of participants
number (confidence interval 95%)	25.0 (8.7 to 49.1)	10.5 (1.3 to 33.1)	5.6 (0.1 to 27.3)	0.0 (0.0 to 18.5)	0.0 (0.0 to 15.4)	4.5 (0.1 to 22.8)	4.5 (0.1 to 22.8)	0.0 (0.0 to 11.9)	4.5 (0.6 to 15.5)

No statistical analyses for this end point

Primary: Median Duration of Response (mDOR) for Part 2 only

Top of page

End point title

Median Duration of Response (mDOR) for Part 2 only ^[8] ^[9]

End point description

Duration of response (DOR) for a participant with BOR of CR or PR is defined as time between the date of first response & the date of the first objectively documented tumor progression per RECIST v1.1 or per PCWG3 criteria for prostate, or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes(whether target or non-target) must have reduction in short axis to <10mm. Partial Response (PR): At least 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study (this includes baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of duration of response 9.99=NA

End point type

Primary

End point timeframe

From the date of first dose to the date of the first objectively documented tumor progression, or death, whichever occurs first (Up to approximately 83 months)

Notes
[8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Qualitative statistics were planned for this endpoint only
[9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Pre-specified to be reported for Part 2 only

End point values	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	5	2	1	0 ^[10]	0 ^[11]	1	1	0 ^[12]	2 ^[13]
Units: Months
median (full range (min-max))	20.53 (3.65 to 20.53)	4.75 (3.71 to 5.78)	7.89 (7.89 to 7.89)	( to )	( to )	5.52 (5.52 to 5.52)	14.88 (14.88 to 14.88)	( to )	9.99 (0.03 to 14.85)

Notes
[10] - No participants were analyzed
[11] - No participants were analyzed
[12] - No participants were analyzed
[13] - Insufficient number of participants to calculate mDOR

No statistical analyses for this end point

Primary: Progression-free Survival Rate (PFSR) at 24, 36, and 48 weeks for Part 2 only

Top of page

End point title

Progression-free Survival Rate (PFSR) at 24, 36, and 48 weeks for Part 2 only ^[14] ^[15]

End point description

Progression-free survival (PFS) for a participant is defined as the time from the first dosing date to the date of first objectively documented disease progression or death due to any cause, whichever occurs first. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of progression-free survival rate

End point type

Primary

End point timeframe

At 24, 36, and 48 weeks

Notes
[14] - 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: Qualitative statistics were planned for this endpoint only
[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: Pre-specified to be reported for Part 2 only

End point values	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	20	19	18	18	22	22	22	29	44
Units: Percent of participants
number (confidence interval 95%)
24 Weeks	31.9 (13.1 to 52.6)	22.2 (6.9 to 42.9)	11.1 (1.9 to 29.8)	11.1 (1.9 to 29.8)	9.1 (1.6 to 25.1)	16.3 (4.2 to 35.5)	37.5 (15.8 to 59.4)	11.7 (3.0 to 27)	7.9 (2.0 to 19.0)
36 Weeks	19.1 (5.1 to 39.9)	11.1 (1.9 to 29.8)	11.1 (1.9 to 29.8)	5.6 (0.4 to 22.4)	9.1 (1.6 to 25.1)	16.3 (4.2 to 35.5)	18.8 (4.7 to 40.1)	7.8 (1.4 to 22.0)	7.9 (2.0 to 19.0)
48 Weeks	19.1 (5.1 to 39.9)	5.6 (0.4 to 22.4)	5.6 (0.4 to 22.4)	5.6 (0.4 to 22.4)	9.1 (1.6 to 25.1)	5.4 (0.4 to 21.9)	18.8 (4.7 to 40.1)	7.8 (1.4 to 22.0)	5.2 (1.0 to 15.4)

No statistical analyses for this end point

Secondary: Objective Response Rate (ORR) for Part1A and Part1B only

Top of page

End point title

Objective Response Rate (ORR) for Part1A and Part1B only ^[16]

End point description

Objective response rate (ORR) is defined as the percent of all treated participants whose best overall response (BOR) is either complete response (CR) or partial response (PR) by Investigator 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 have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition to the relative increase of 20%, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression).

End point type

Secondary

End point timeframe

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: Pre-specified to be reported for Part1A and Part1B only

Part 1A: BMS-986218 2 mg

Part 1A: BMS-986218 4 mg

Part 1A: BMS-986218 7 mg

Part 1A: BMS-986218 20 mg

Part 1A: BMS-986218 40 mg

Part 1A: BMS-986218 70 mg

Part 1A: BMS-986218 100 mg

Part 1A: BMS-986218 150 mg

Part 1A: BMS-986218 200 mg

Part 1A: BMS-986218 20 mg

Part 1A: BMS-986218 35 mg

Part 1A: BMS-986218 50 mg

Part 1A: BMS-986218 20 mg PD

Part 1B: BMS-986218 7 mg + Nivo 480 mg

Part 1B: BMS-986218 20 mg + Nivo 480 mg

Part 1B: BMS-986218 40 mg + Nivo 480 mg

Part 1B: BMS-986218 70 mg + Nivo 480 mg

Number of subjects analysed

Units: Percent of participants

number (confidence interval 95%)

0.0 (0.0 to 60.2)

0.0 (0.0 to 33.6)

0.0 (0.0 to 26.5)

0.0 (0.0 to 21.8)

0.0 (0.0 to 26.5)

0.0 (0.0 to 23.2)

14.3 (0.4 to 57.9)

0.0 (0.0 to 28.5)

0.0 (0.0 to 52.2)

7.1 (0.2 to 33.9)

0.0 (0.0 to 45.9)

0.0 (0.0 to 60.2)

0.0 (0.0 to 97.5)

0.0 (0.0 to 52.2)

0.0 (0.0 to 19.5)

5.3 (0.1 to 26.0)

28.6 (3.7 to 71.0)

No statistical analyses for this end point

Secondary: Median Duration of Response (mDOR) for Part1A and Part1B only

Top of page

End point title

Median Duration of Response (mDOR) for Part1A and Part1B only ^[17]

End point description

Duration of response (DOR) for a participant with a BOR of CR or PR is defined as the time between the date of first response and the date of the first objectively documented tumor progression per RECIST v1.1 or death, whichever occurs first. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to <10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of the diameters of target lesions, taking as reference the smallest sum on study (this includes the baseline sum if that is the smallest on study). In addition, the sum must also demonstrate an absolute increase of at least 5mm (Note: The appearance of 1or more new lesions is also considered progression). Based on Kaplan-Meier estimates of duration of response

End point type

Secondary

End point timeframe

From the date of first dose to the date of the first objectively documented tumor progression, or death, whichever occurs first (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: Pre-specified to be reported for Part1A and Part1B only

Part 1A: BMS-986218 2 mg

Part 1A: BMS-986218 4 mg

Part 1A: BMS-986218 7 mg

Part 1A: BMS-986218 20 mg

Part 1A: BMS-986218 40 mg

Part 1A: BMS-986218 70 mg

Part 1A: BMS-986218 100 mg

Part 1A: BMS-986218 150 mg

Part 1A: BMS-986218 200 mg

Part 1A: BMS-986218 20 mg

Part 1A: BMS-986218 35 mg

Part 1A: BMS-986218 50 mg

Part 1A: BMS-986218 20 mg PD

Part 1B: BMS-986218 7 mg + Nivo 480 mg

Part 1B: BMS-986218 20 mg + Nivo 480 mg

Part 1B: BMS-986218 40 mg + Nivo 480 mg

Part 1B: BMS-986218 70 mg + Nivo 480 mg

Number of subjects analysed

Units: Percent of participants

number (confidence interval 95%)

0.0 (0.0 to 60.2)

0.0 (0.0 to 33.6)

0.0 (0.0 to 26.5)

0.0 (0.0 to 21.8)

0.0 (0.0 to 26.5)

0.0 (0.0 to 23.2)

14.3 (0.4 to 57.9)

0.0 (0.0 to 28.5)

0.0 (0.0 to 52.2)

7.1 (0.2 to 33.9)

0.0 (0.0 to 45.9)

0.0 (0.0 to 60.2)

0.0 (0.0 to 97.5)

0.0 (0.0 to 52.2)

0.0 (0.0 to 19.5)

5.3 (0.1 to 26.0)

28.6 (3.7 to 71.0)

No statistical analyses for this end point

Secondary: Progression-free Survival Rate (PFSR) at 24, 36, and 48 weeks for Part1A and Part1B only

Top of page

End point title

Progression-free Survival Rate (PFSR) at 24, 36, and 48 weeks for Part1A and Part1B only ^[18]

End point description

End point type

Secondary

End point timeframe

At 24, 36, and 48 weeks

Notes
[18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Pre-specified to be reported for Part1A and Part1B only

Part 1A: BMS-986218 2 mg

Part 1A: BMS-986218 4 mg

Part 1A: BMS-986218 7 mg

Part 1A: BMS-986218 20 mg

Part 1A: BMS-986218 40 mg

Part 1A: BMS-986218 70 mg

Part 1A: BMS-986218 100 mg

Part 1A: BMS-986218 150 mg

Part 1A: BMS-986218 200 mg

Part 1A: BMS-986218 20 mg

Part 1A: BMS-986218 35 mg

Part 1A: BMS-986218 50 mg

Part 1A: BMS-986218 20 mg PD

Part 1B: BMS-986218 7 mg + Nivo 480 mg

Part 1B: BMS-986218 20 mg + Nivo 480 mg

Part 1B: BMS-986218 40 mg + Nivo 480 mg

Part 1B: BMS-986218 70 mg + Nivo 480 mg

Number of subjects analysed

Units: Percent of participants

number (confidence interval 95%)

24 Weeks

33.3 (0.9 to 77.4)

22.2 (3.4 to 51.3)

16.7 (2.7 to 41.3)

15.4 (2.5 to 38.8)

9.1 (0.5 to 33.3)

0.0 (0.0 to 0.0)

17.1 (0.8 to 52.6)

9.1 (0.5 to 33.3)

0.0 (0.0 to 0.0)

7.1 (0.5 to 27.5)

16.7 (0.8 to 51.7)

50.0 (5.8 to 84.5)

0.0 (0.0 to 0.0)

20.0 (0.8 to 58.2)

9.5 (0.6 to 33.5)

11.1 (1.9 to 29.8)

28.6 (4.1 to 61.2)

36 Weeks

0.0 (0.0 to 0.0)

22.2 (3.4 to 51.3)

0.0 (0.0 to 0.0)

7.7 (0.5 to 29.2)

9.1 (0.5 to 33.3)

0.0 (0.0 to 0.0)

99999 (99999 to 99999)

9.1 (0.5 to 33.3)

0.0 (0.0 to 0.0)

7.1 (0.5 to 27.5)

0.0 (0.0 to 0.0)

50.0 (5.8 to 84.5)

0.0 (0.0 to 0.0)

11.1 (1.9 to 29.8)

28.6 (4.1 to 61.2)

48 Weeks

0.0 (0.0 to 0.0)

7.7 (0.5 to 29.2)

9.1 (0.5 to 33.3)

0.0 (0.0 to 0.0)

99999 (99999 to 99999)

9.1 (0.5 to 33.3)

0.0 (0.0 to 0.0)

11.1 (1.9 to 29.8)

28.6 (4.1 to 61.2)

No statistical analyses for this end point

Secondary: Maximum Observed Serum Concentration (Cmax) for BMS-986218

Top of page

End point title

Maximum Observed Serum Concentration (Cmax) for BMS-986218

End point description

Cmax is the maximum observed serum concentration. 99999=NA

End point type

Secondary

End point timeframe

On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	4	9	12	15	12	14	7	11	5	14	6	4	1	5	17	18	7	0 ^[19]	15	17	17	20	20	20	27	41
Units: ng/mL
geometric mean (geometric coefficient of variation)
Cycle 1 Day 1	378.20 ( 69.94 )	898.37 ( 35.77 )	1918.89 ( 27.17 )	5162.91 ( 31.89 )	10167.06 ( 34.47 )	19191.31 ( 23.63 )	28404.67 ( 25.91 )	38955.95 ( 46.84 )	34268.86 ( 30.14 )	5198.38 ( 23.13 )	6774.51 ( 32.40 )	13852.30 ( 22.40 )	3800.00 ( 99999 )	2196.42 ( 34.99 )	4009.69 ( 40.55 )	7672.60 ( 39.22 )	17399.93 ( 29.04 )	( )	2096.56 ( 42.66 )	4759.66 ( 46.15 )	17121.28 ( 22.99 )	2207.18 ( 102.83 )	5890.68 ( 60.79 )	16114.18 ( 37.86 )	9545.23 ( 39.78 )	8977.53 ( 38.23 )
Cycle 1 Day 15	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	6039.57 ( 32.03 )	8958.71 ( 30.62 )	17041.16 ( 16.18 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	( )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
Cycle 3 Day 1	636.63 ( 12.17 )	1041.61 ( 22.08 )	1984.34 ( 20.51 )	5013.30 ( 40.59 )	9461.39 ( 51.18 )	23878.44 ( 10.92 )	26728.01 ( 38.43 )	40591.79 ( 11.96 )	99999 ( 99999 )	5198.25 ( 15.55 )	9896.67 ( 9.69 )	17526.84 ( 32.21 )	5870.00 ( 99999 )	1849.00 ( 25.58 )	3568.33 ( 47.96 )	7900.78 ( 29.53 )	14300.00 ( 99999 )	( )	2430.88 ( 30.45 )	7837.32 ( 169.78 )	16491.17 ( 26.01 )	2812.74 ( 52.12 )	6236.74 ( 37.92 )	23527.72 ( 50.87 )	10711.87 ( 28.93 )	10317.85 ( 42.91 )
Cycle 3 Day 15	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	5485.98 ( 30.70 )	9090.35 ( 13.17 )	13100.00 ( 99999 )	6540.00 ( 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 )

Notes
[19] - No participants were analyzed

No statistical analyses for this end point

Secondary: Area under the Concentration-time Curve from Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218

Top of page

End point title

Area under the Concentration-time Curve from Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218

End point description

Tmax is the time taken to reach the maximum observed serum concentration (Cmax). 99999=NA

End point type

Secondary

End point timeframe

On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	4	9	12	15	12	14	7	11	5	14	6	4	1	5	17	18	7	0 ^[20]	15	17	17	20	20	20	27	41
Units: h*ng/mL
geometric mean (geometric coefficient of variation)
Cycle 1 Day 1	38482.79 ( 67.05 )	152995.20 ( 24.90 )	338090.13 ( 44.06 )	859624.01 ( 35.00 )	1374751.12 ( 41.91 )	2800743.92 ( 34.47 )	4813781.16 ( 28.58 )	6332567.97 ( 32.76 )	6471486.44 ( 42.01 )	555237.58 ( 35.05 )	911929.11 ( 36.66 )	1878893.05 ( 27.29 )	698634.55 ( 99999 )	346844.14 ( 43.83 )	568755.53 ( 50.38 )	1196906.59 ( 39.01 )	2675458.62 ( 25.81 )	( )	362116.78 ( 42.58 )	1001283.21 ( 50.58 )	3086017.57 ( 21.62 )	352268.83 ( 78.80 )	1067646.86 ( 40.62 )	2733292.53 ( 35.02 )	1461119.11 ( 35.96 )	1380362.22 ( 42.32 )
Cycle 1 Day 15	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	666441.31 ( 50.63 )	812419.15 ( 67.75 )	2710445.36 ( 7.15 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	( )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
Cycle 3 Day 1	106995.38 ( 25.94 )	180870.63 ( 13.77 )	320865.91 ( 52.33 )	916409.73 ( 31.83 )	1231569.13 ( 60.51 )	4712195.98 ( 22.69 )	4496192.21 ( 30.37 )	7327105.74 ( 35.84 )	99999 ( 99999 )	829253.53 ( 24.59 )	1673664.31 ( 29.67 )	1162456.20 ( 123.44 )	1058967.60 ( 99999 )	284245.76 ( 46.27 )	586413.48 ( 57.48 )	1530718.58 ( 31.46 )	2090995.50 ( 99999 )	( )	242498.24 ( 71.75 )	1070790.34 ( 205.76 )	2152498.70 ( 42.12 )	303622.32 ( 52.88 )	982950.43 ( 51.34 )	3653192.45 ( 34.54 )	1609530.93 ( 45.25 )	1716552.20 ( 22.69 )
Cycle 3 Day 15	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	753989.60 ( 57.54 )	1853267.79 ( 11.48 )	1619652.01 ( 99999 )	732535.33 ( 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 )

Notes
[20] - No participants were analyzed

No statistical analyses for this end point

Secondary: Area under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218

Top of page

End point title

Area under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218

End point description

AUC (TAU) is the area measured under the concentration-time curve taken over the dosing interval. 99999=NA

End point type

Secondary

End point timeframe

On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	2	9	11	13	11	14	7	10	4	11	5	4	1	5	14	15	7	0 ^[21]	15	16	17	20	20	19	26	36
Units: h*ng/mL
geometric mean (geometric coefficient of variation)
Cycle 1 Day 1	102107.56 ( 20.44 )	160708.57 ( 21.45 )	376035.72 ( 38.14 )	894413.40 ( 35.17 )	1421515.99 ( 40.74 )	3027482.69 ( 33.30 )	4816815.14 ( 23.87 )	6599896.79 ( 22.75 )	7560614.03 ( 28.48 )	604538.01 ( 32.38 )	984127.10 ( 33.75 )	1878893.05 ( 27.29 )	698634.55 ( 99999 )	346844.14 ( 43.83 )	765535.55 ( 37.86 )	1400907.18 ( 31.92 )	2736051.44 ( 25.50 )	( )	355092.73 ( 43.60 )	1107418.00 ( 43.18 )	3074048.83 ( 19.62 )	366958.19 ( 75.83 )	1096040.02 ( 38.84 )	2884299.15 ( 30.80 )	1488804.73 ( 35.18 )	1516016.83 ( 38.72 )
Cycle 1 Day 15	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	791252.01 ( 42.41 )	1254494.19 ( 41.07 )	2710445.36 ( 7.15 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	( )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
Cycle 3 Day 1	110809.32 ( 21.12 )	189406.70 ( 12.74 )	460618.56 ( 29.45 )	946000.30 ( 44.09 )	1265811.65 ( 67.93 )	4008112.03 ( 99999 )	5131052.16 ( 1.63 )	7635138.59 ( 31.66 )	99999 ( 99999 )	829253.53 ( 24.59 )	1673664.31 ( 29.67 )	3363278.02 ( 99999 )	1058967.60 ( 99999 )	284245.76 ( 46.27 )	827831.27 ( 33.07 )	1569751.67 ( 32.78 )	2090995.50 ( 99999 )	( )	438160.20 ( 44.33 )	1777132.02 ( 156.77 )	2986930.70 ( 24.50 )	471293.82 ( 33.36 )	1189672.74 ( 38.19 )	3636946.89 ( 34.65 )	1650434.22 ( 44.45 )	1760069.89 ( 26.26 )
Cycle 3 Day 15	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1161185.91 ( 99999 )	1853267.79 ( 11.48 )	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 )

Notes
[21] - No participants were analyzed

No statistical analyses for this end point

Secondary: Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218

Top of page

End point title

Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218

End point description

Ctau is the observed serum concentration at the end of the dosing interval. 99999=NA

End point type

Secondary

End point timeframe

On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	2	9	11	13	11	14	7	10	4	11	5	4	1	5	14	15	7	0 ^[22]	15	16	17	20	20	19	26	36
Units: ng/mL
geometric mean (geometric coefficient of variation)
Cycle 1 Day 1	39.29 ( 18.84 )	54.25 ( 46.26 )	184.40 ( 53.72 )	304.84 ( 66.34 )	293.28 ( 82.69 )	792.03 ( 76.23 )	1600.37 ( 31.94 )	2396.65 ( 51.08 )	2659.87 ( 32.41 )	703.99 ( 45.94 )	1284.78 ( 42.93 )	2793.34 ( 31.31 )	1090.00 ( 99999 )	99.96 ( 45.22 )	176.14 ( 63.80 )	466.01 ( 67.94 )	667.59 ( 62.14 )	( )	140.54 ( 62.61 )	530.35 ( 144.43 )	959.00 ( 56.06 )	133.30 ( 118.13 )	379.50 ( 62.15 )	810.78 ( 69.02 )	330.53 ( 65.42 )	341.97 ( 74.43 )
Cycle 1 Day 15	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1016.63 ( 57.51 )	1651.22 ( 51.66 )	3630.54 ( 21.56 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	( )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
Cycle 3 Day 1	43.06 ( 73.10 )	88.58 ( 30.12 )	239.24 ( 37.53 )	275.23 ( 54.82 )	262.71 ( 106.82 )	2310.00 ( 99999 )	2089.02 ( 33.02 )	3151.12 ( 64.09 )	99999 ( 99999 )	1098.35 ( 31.92 )	2723.07 ( 23.06 )	5161.39 ( 99999 )	1550.00 ( 99999 )	140.76 ( 67.67 )	294.67 ( 34.83 )	559.93 ( 63.00 )	339.00 ( 99999 )	( )	154.17 ( 76.15 )	795.20 ( 166.56 )	1033.06 ( 33.10 )	195.37 ( 39.51 )	442.46 ( 66.32 )	1326.75 ( 50.09 )	423.20 ( 85.57 )	516.44 ( 58.12 )
Cycle 3 Day 15	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1980.00 ( 99999 )	3212.85 ( 27.42 )	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 )

Notes
[22] - No participants were analyzed

No statistical analyses for this end point

Secondary: Total Body Clearance (CLT/F) for BMS-986218

Top of page

End point title

Total Body Clearance (CLT/F) for BMS-986218

End point description

99999=NA

End point type

Secondary

End point timeframe

At Cycle 3 Day 1 (Each Cycle is of 28 Days)

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	2	4	5	3	4	1	2	4	0 ^[23]	3	2	1	1	2	3	6	1	0 ^[24]	10	8	6	7	10	10	11	9
Units: mL/h
geometric mean (geometric coefficient of variation)	18.05 ( 21.12 )	21.12 ( 13.87 )	15.20 ( 43.36 )	21.14 ( 59.06 )	31.60 ( 61.89 )	17.46 ( 99999 )	19.49 ( 1.63 )	19.65 ( 30.54 )	( )	24.12 ( 22.83 )	20.91 ( 29.67 )	14.87 ( 99999 )	18.89 ( 99999 )	24.63 ( 46.27 )	24.16 ( 40.86 )	25.48 ( 37.36 )	33.48 ( 99999 )	( )	15.98 ( 51.15 )	11.25 ( 57.31 )	23.44 ( 31.87 )	14.85 ( 27.95 )	16.81 ( 33.59 )	19.25 ( 45.86 )	24.24 ( 60.65 )	22.73 ( 20.24 )

Notes
[23] - No Participants were analyzed
[24] - No participants were analyzed

No statistical analyses for this end point

Secondary: Average Concentration over a Dosing Interval (AUC[TAU]/tau) at Steady State (Css-avg) for BMS-986218

Top of page

End point title

Average Concentration over a Dosing Interval (AUC[TAU]/tau) at Steady State (Css-avg) for BMS-986218

End point description

99999=NA

End point type

Secondary

End point timeframe

At Cycle 3 Day 1 (Each Cycle is of 28 Days)

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	2	4	5	3	4	1	2	4	0 ^[25]	3	2	1	1	2	3	6	1	0 ^[26]	10	8	6	7	10	10	11	9
Units: ng/mL
geometric mean (geometric coefficient of variation)	165.22 ( 21.39 )	282.04 ( 12.75 )	686.31 ( 29.48 )	1393.64 ( 45.15 )	1881.64 ( 68.23 )	5980.92 ( 99999 )	7644.60 ( 1.80 )	11589.37 ( 35.71 )	( )	2420.43 ( 20.98 )	5006.22 ( 29.63 )	10009.76 ( 99999 )	3142.64 ( 99999 )	448.98 ( 43.83 )	1234.39 ( 32.97 )	2334.85 ( 32.57 )	2490.67 ( 99999 )	( )	659.08 ( 44.76 )	2633.76 ( 157.01 )	4303.25 ( 21.87 )	685.48 ( 34.93 )	1760.14 ( 35.04 )	5347.42 ( 32.03 )	2429.04 ( 43.75 )	2627.53 ( 26.08 )

Notes
[25] - No participants were analyzed
[26] - No participants were analyzed

No statistical analyses for this end point

Secondary: Ratio of an Exposure Measure at Steady State to that After the First Dose (Exposure Measure includes Cmax) (AI_Cmax) for BMS-986218

Top of page

End point title

Ratio of an Exposure Measure at Steady State to that After the First Dose (Exposure Measure includes Cmax) (AI_Cmax) for BMS-986218

End point description

99999=NA

End point type

Secondary

End point timeframe

At Cycle 3 Day 1 (Each Cycle is of 28 Days)

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	2	4	6	4	4	2	3	4	0 ^[27]	3	2	2	1	2	4	7	1	0 ^[28]	12	12	8	10	12	10	11	9
Units: Ratio
geometric mean (geometric coefficient of variation)	0.83 ( 10.89 )	1.15 ( 22.83 )	1.13 ( 22.62 )	1.22 ( 52.14 )	0.91 ( 6.40 )	1.10 ( 8.26 )	0.77 ( 39.73 )	1.32 ( 1.53 )	( )	1.12 ( 8.28 )	1.26 ( 53.95 )	1.29 ( 5.21 )	1.54 ( 99999 )	1.07 ( 8.70 )	0.77 ( 37.44 )	0.84 ( 27.10 )	1.08 ( 99999 )	( )	1.19 ( 80.37 )	1.71 ( 115.10 )	0.90 ( 21.26 )	1.33 ( 93.11 )	1.00 ( 52.38 )	1.45 ( 136.48 )	1.05 ( 20.63 )	1.18 ( 40.84 )

Notes
[27] - No participants were analyzed
[28] - No participants were analyzed

No statistical analyses for this end point

Secondary: Accumulation Index Ratio of AUC at Steady State to that After the First Dose (AI_AUC) for BMS-986218

Top of page

End point title

Accumulation Index Ratio of AUC at Steady State to that After the First Dose (AI_AUC) for BMS-986218

End point description

99999=NA

End point type

Secondary

End point timeframe

At Cycle 3 Day 1 (Each Cycle is of 28 Days)

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	2	4	5	3	4	1	2	4	0 ^[29]	2	2	1	1	2	3	6	1	0 ^[30]	9	8	6	7	10	10	11	9
Units: Ratio
geometric mean (geometric coefficient of variation)	1.09 ( 0.69 )	1.16 ( 28.89 )	1.43 ( 26.71 )	1.29 ( 25.00 )	0.81 ( 17.94 )	1.16 ( 99999 )	1.09 ( 8.11 )	1.16 ( 17.02 )	( )	1.49 ( 2.93 )	1.43 ( 54.87 )	1.28 ( 99999 )	1.52 ( 99999 )	1.09 ( 15.24 )	1.09 ( 15.52 )	1.13 ( 13.09 )	1.13 ( 99999 )	( )	1.36 ( 96.87 )	1.37 ( 104.97 )	0.93 ( 25.69 )	1.48 ( 47.11 )	0.98 ( 34.75 )	1.29 ( 27.70 )	1.04 ( 19.75 )	1.18 ( 31.02 )

Notes
[29] - No participants were analyzed
[30] - No participants were analyzed

No statistical analyses for this end point

Secondary: Terminal Serum Half-life (T-HALF) for BMS-986218

Top of page

End point title

Terminal Serum Half-life (T-HALF) for BMS-986218

End point description

99999=NA

End point type

Secondary

End point timeframe

At Cycle 3 Day 1 (Each Cycle is of 28 Days)

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	2	4	5	3	4	1	2	4	0 ^[31]	2	1	1	0 ^[32]	2	3	5	1	0 ^[33]	10	8	6	7	10	10	11	9
Units: hour
geometric mean (geometric coefficient of variation)	233.28 ( 50.61 )	264.58 ( 16.51 )	274.01 ( 23.40 )	191.02 ( 19.95 )	175.33 ( 34.46 )	331.17 ( 99999 )	290.94 ( 6.57 )	234.91 ( 23.01 )	( )	191.02 ( 4.42 )	200.61 ( 99999 )	211.88 ( 99999 )	( )	213.34 ( 4.94 )	203.14 ( 2.92 )	205.63 ( 25.20 )	194.21 ( 99999 )	( )	224.90 ( 33.11 )	271.49 ( 24.13 )	207.59 ( 16.53 )	233.09 ( 11.04 )	230.66 ( 32.95 )	235.80 ( 23.08 )	201.22 ( 41.29 )	198.93 ( 32.68 )

Notes
[31] - No participants were analyzed
[32] - Participant was not analyzed
[33] - No participants were analyzed

No statistical analyses for this end point

Secondary: Time of Maximum Observed Concentration (Tmax) for BMS-986218

Top of page

End point title

Time of Maximum Observed Concentration (Tmax) for BMS-986218

End point description

Tmax is the time taken to reach the maximum observed serum concentration (Cmax). 99999=NA

End point type

Secondary

End point timeframe

On Cycle 1 Day 1, Cycle 1 Day 15, Cycle 3 Day 1, Cycle 3 Day 15 (Each Cycle is of 28 Days)

Part 1A: BMS-986218 2 mg

Part 1A: BMS-986218 4 mg

Part 1A: BMS-986218 7 mg

Part 1A: BMS-986218 20 mg

Part 1A: BMS-986218 40 mg

Part 1A: BMS-986218 70 mg

Part 1A: BMS-986218 100 mg

Part 1A: BMS-986218 150 mg

Part 1A: BMS-986218 200 mg

Part 1A: BMS-986218 20 mg

Part 1A: BMS-986218 35 mg

Part 1A: BMS-986218 50 mg

Part 1A: BMS-986218 20 mg PD

Part 1B: BMS-986218 7 mg + Nivo 480 mg

Part 1B: BMS-986218 20 mg + Nivo 480 mg

Part 1B: BMS-986218 40 mg + Nivo 480 mg

Part 1B: BMS-986218 70 mg + Nivo 480 mg

Part 2A: Ipilimumab Cutaneous Melanoma

Part 2A: BMS-986218 7 mg Cutaneous Melanoma

Part 2A: BMS-986218 20 mg Cutaneous Melanoma

Part 2A: BMS-986218 70 mg Cutaneous Melanoma

Part 2B: BMS-986218 7 mg NSCLC

Part 2B: BMS-986218 20 mg NSCLC

Part 2B: BMS-986218 70 mg NSCLC

Part 2C: BMS-986218 + Nivo NSCLC

Part 2D: BMS-986218 + Nivo MSS CRC

Number of subjects analysed

0 ^[34]

Units: hour

median (full range (min-max))

Cycle 1 Day 1

2.04 (0.07 to 168.08)

0.35 (0.13 to 4.13)

0.48 (0.23 to 4.00)

0.53 (0.47 to 24.58)

0.52 (0.42 to 0.60)

0.54 (0.47 to 24.00)

0.70 (0.52 to 24.83)

0.53 (0.47 to 25.08)

0.60 (0.50 to 24.58)

0.56 (0.50 to 21.87)

11.51 (0.47 to 24.52)

0.53 (0.50 to 0.58)

20.93 (20.93 to 20.93)

0.27 (0.12 to 24.23)

0.52 (0.47 to 24.07)

0.60 (0.47 to 166.17)

0.62 (0.35 to 24.43)

( to )

0.30 (0.23 to 24.35)

0.58 (0.47 to 166.58)

0.58 (0.47 to 24.25)

0.27 (0.20 to 24.32)

9.88 (0.42 to 162.42)

0.53 (0.03 to 25.30)

0.65 (0.50 to 22.50)

0.92 (0.50 to 72.93)

Cycle 1 Day 15

99999 (99999 to 99999)

0.52 (0.48 to 44.73)

12.28 (0.50 to 25.72)

12.15 (0.53 to 24.18)

99999 (99999 to 99999)

( to )

99999 (99999 to 99999)

Cycle 3 Day 1

2.05 (0.10 to 4.00)

2.08 (0.10 to 4.00)

0.48 (0.25 to 4.33)

12.24 (0.50 to 24.00)

0.51 (0.42 to 0.53)

0.68 (0.55 to 0.82)

0.50 (0.50 to 0.70)

0.53 (0.52 to 24.50)

99999 (99999 to 99999)

0.53 (0.47 to 0.53)

12.41 (0.82 to 24.00)

0.64 (0.53 to 0.75)

0.52 (0.52 to 0.52)

0.33 (0.25 to 0.40)

21.06 (0.52 to 24.62)

0.53 (0.47 to 21.82)

0.75 (0.75 to 0.75)

( to )

0.27 (0.20 to 24.00)

0.53 (0.50 to 24.00)

0.53 (0.47 to 167.92)

0.28 (0.23 to 164.97)

0.56 (0.47 to 24.60)

0.52 (0.47 to 24.50)

0.68 (0.00 to 24.00)

0.75 (0.50 to 4.92)

Cycle 3 Day 15

99999 (99999 to 99999)

0.53 (0.53 to 0.53)

12.26 (0.52 to 24.00)

0.53 (0.53 to 0.53)

99999 (99999 to 99999)

( to )

99999 (99999 to 99999)

Notes
[34] - No participants were analyzed

No statistical analyses for this end point

Secondary: Trough Observed Plasma Concentration (Ctrough) for BMS-986218

Top of page

End point title

Trough Observed Plasma Concentration (Ctrough) for BMS-986218

End point description

Ctrough is the lowest observed serum concentration. 99999=NA

End point type

Secondary

End point timeframe

At Cycle 1 Day 15, Cycle 2 Day 1, Cycle 2 Day 15, Cycle 3 Day 1, Cycle 3 Day 15, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 7 Day 1, Cycle 9 Day 1, Cycle 13 Day 1, Cycle 17 Day 1, Cycle 21 Day 1 (Each Cycle is of 28 Days)

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	3	6	9	7	8	5	3	4	3	10	4	4	1	5	11	9	5	0 ^[35]	14	13	13	17	16	15	21	24
Units: ng/ml
geometric mean (geometric coefficient of variation)
Cycle 1 Day 15	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	751.99 ( 42.10 )	1501.35 ( 32.91 )	2793.34 ( 31.31 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	( )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
Cycle 2 Day 1	25.00 ( 0.00 )	55.05 ( 54.39 )	182.56 ( 59.17 )	341.81 ( 49.20 )	524.48 ( 65.16 )	1310.07 ( 42.38 )	1651.31 ( 39.58 )	2427.50 ( 68.46 )	2460.51 ( 38.43 )	1016.63 ( 57.51 )	1651.22 ( 51.66 )	3630.54 ( 21.56 )	99999 ( 99999 )	99.96 ( 45.22 )	217.64 ( 62.28 )	466.94 ( 66.02 )	607.17 ( 75.73 )	( )	129.05 ( 70.92 )	587.71 ( 143.00 )	1064.56 ( 48.39 )	141.23 ( 113.06 )	407.90 ( 62.10 )	1076.42 ( 60.99 )	423.18 ( 63.54 )	383.71 ( 71.78 )
Cycle 2 Day 15	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1063.74 ( 53.79 )	1547.03 ( 61.55 )	3029.39 ( 57.40 )	1450.00 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	( )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
Cycle 3 Day 1	41.86 ( 67.07 )	66.16 ( 45.96 )	297.97 ( 123.19 )	457.55 ( 55.91 )	229.14 ( 72.40 )	2337.71 ( 14.44 )	1260.06 ( 65.56 )	3163.13 ( 56.11 )	99999 ( 99999 )	1174.88 ( 44.26 )	1266.41 ( 105.11 )	2637.27 ( 33.60 )	1860.00 ( 99999 )	59.16 ( 98.57 )	191.74 ( 68.64 )	356.38 ( 54.16 )	319.00 ( 99999 )	( )	158.43 ( 77.94 )	459.88 ( 79.40 )	961.90 ( 41.84 )	224.06 ( 49.56 )	455.88 ( 69.43 )	1721.74 ( 44.78 )	532.21 ( 192.34 )	346.90 ( 55.72 )
Cycle 3 Day 15	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1273.50 ( 25.66 )	2723.07 ( 23.06 )	1930.00 ( 99999 )	1550.00 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	( )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
Cycle 4 Day 1	76.30 ( 99999 )	65.16 ( 60.55 )	239.17 ( 42.21 )	149.00 ( 99999 )	119.37 ( 129.54 )	2310.00 ( 99999 )	2650.00 ( 99999 )	5028.98 ( 43.48 )	99999 ( 99999 )	1980.00 ( 99999 )	3212.85 ( 27.42 )	99999 ( 99999 )	99999 ( 99999 )	140.76 ( 67.67 )	159.03 ( 70.17 )	592.11 ( 63.58 )	339.00 ( 99999 )	( )	190.56 ( 64.87 )	536.11 ( 51.32 )	850.80 ( 10.98 )	179.31 ( 37.25 )	579.85 ( 57.85 )	1473.97 ( 45.56 )	365.27 ( 102.58 )	734.46 ( 37.26 )
Cycle 5 Day 1	57.70 ( 99999 )	76.43 ( 45.86 )	219.06 ( 30.71 )	155.00 ( 99999 )	243.09 ( 36.27 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1890.00 ( 99999 )	3840.00 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	255.00 ( 99999 )	448.60 ( 8.97 )	1013.99 ( 84.49 )	99999 ( 99999 )	( )	209.59 ( 52.65 )	704.66 ( 24.65 )	1902.00 ( 31.19 )	108.85 ( 49.50 )	460.96 ( 112.61 )	1462.14 ( 44.11 )	318.78 ( 94.16 )	518.96 ( 71.39 )
Cycle 7 Day 1	80.30 ( 99999 )	46.34 ( 77.66 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	( )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )
Cycle 9 Day 1	99999 ( 99999 )	85.46 ( 61.35 )	356.00 ( 99999 )	99999 ( 99999 )	196.00 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	1710.00 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	232.00 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	( )	570.00 ( 99999 )	770.00 ( 99999 )	932.00 ( 99999 )	123.00 ( 99999 )	2030.00 ( 99999 )	2110.00 ( 99999 )	99999 ( 99999 )	646.00 ( 99999 )
Cycle 13 Day 1	99999 ( 99999 )	67.50 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	891.00 ( 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 )	( )	533.00 ( 99999 )	706.00 ( 99999 )	1020.00 ( 99999 )	203.00 ( 99999 )	99999 ( 99999 )	1470.00 ( 99999 )	99999 ( 99999 )	1820.00 ( 99999 )
Cycle 17 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 )	99999 ( 99999 )	( )	335.00 ( 99999 )	357.00 ( 99999 )	99999 ( 99999 )	231.00 ( 99999 )	99999 ( 99999 )	1150.00 ( 99999 )	99999 ( 99999 )	1600.00 ( 99999 )
Cycle 21 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 )	99999 ( 99999 )	( )	99999 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )	169.00 ( 99999 )	99999 ( 99999 )	715.00 ( 99999 )	99999 ( 99999 )	99999 ( 99999 )

Notes
[35] - No participants were analyzed

No statistical analyses for this end point

Secondary: Number of Participants with Anti-drug Antibodies (ADA) to BMS-986218

Top of page

End point title

Number of Participants with Anti-drug Antibodies (ADA) to BMS-986218

End point description

Baseline ADA Positive: Participant with baseline ADA-positive sample ADA Positive: Participant with at least one ADA-positive sample relative to baseline (ADA negative at baseline or ADA titer to be at least 4-fold or greater (>=) than baseline positive titer) at any time after initiation of treatment Persistent Positive (PP): ADA-positive sample at 2 or more consecutive timepoints, where the first and last ADA-positive samples are at least 16weeks apart Not PP-Last Sample Positive: Not persistent but with ADA-positive sample at the last sampling timepoint Other Positive: Not persistent but some ADA-positive samples with the last sample being negative ADA Negative: Participant with no ADA-positive sample after initiation of treatment

End point type

Secondary

End point timeframe

From first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months)

End point values	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 20 mg PD	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 2A: Ipilimumab Cutaneous Melanoma	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2B: BMS-986218 7 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2C: BMS-986218 + Nivo NSCLC	Part 2D: BMS-986218 + Nivo MSS CRC
Number of subjects analysed	4	7	10	13	9	10	4	7	5	8	5	3	0 ^[36]	4	12	11	6	0 ^[37]	18	14	11	19	19	17	20	26
Units: Participants
Baseline ADA Positive	0	0	0	1	0	1	0	0	0	1	0	1		0	0	0	0		2	0	1	0	1	0	0	0
ADA Positive	0	1	0	1	0	3	1	0	0	1	0	1		0	2	0	0		0	1	1	0	1	0	0	0
ADA Positive [Persistent Positive (PP)]	0	0	0	0	0	0	0	0	0	0	0	0		0	0	0	0		0	0	0	0	0	0	0	0
ADA Positive [Not PP-Last Sample Positive]	0	0	0	1	0	2	1	0	0	0	0	1		0	2	0	0		0	1	0	0	0	0	0	0
ADA Positive [Other Positive]	0	1	0	0	0	1	0	0	0	1	0	0		0	0	0	0		0	0	1	0	1	0	0	0
ADA Negative	4	6	10	12	9	7	3	7	5	7	5	2		4	10	11	6		18	13	10	19	18	17	20	26

Notes
[36] - Participant was not analyzed
[37] - No participants were analyzed

No statistical analyses for this end point

Adverse events

Top of page

Timeframe for reporting adverse events

SAEs and Other AEs were assessed from first dose of study medication through 100 days following last dose of study treatment (assessed for an average of 8 months up to a max of approximately 28 months).

Adverse event reporting additional description

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

27.0

Reporting group title

Part 1A: BMS-986218 70 mg

Reporting group description

Participants received BMS-986218 at 70 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 40 mg

Reporting group description

Participants received BMS-986218 at 40 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 20 mg

Reporting group description

Participants received BMS-986218 at 20 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 7 mg

Reporting group description

Participants received BMS-986218 at 7 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 4 mg

Reporting group description

Participants received BMS-986218 at 4 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 2 mg

Reporting group description

Participants received BMS-986218 at 2 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 50 mg

Reporting group description

Participants received BMS-986218 at 50 mg every 2 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 35 mg

Reporting group description

Participants received BMS-986218 at 35 mg every 2 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 20 mg

Reporting group description

Participants received BMS-986218 at 20 mg every 2 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 200 mg

Reporting group description

Participants received BMS-986218 at 200 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 150 mg

Reporting group description

Participants received BMS-986218 at 150 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 100 mg

Reporting group description

Participants received BMS-986218 at 100 mg every 4 weeks for up to 2 years

Reporting group title

Part 1A: BMS-986218 20 mg PD

Reporting group description

Participants received BMS-986218 at 20 mg every 2 weeks

Reporting group title

Part 2A: BMS-986218 7 mg Cutaneous Melanoma

Reporting group description

Participants received BMS-986218 at 7 mg every 4 weeks

Reporting group title

Part 2A: Ipilimumab Cutaneous Melanoma

Reporting group description

Participants received ipilimumab at 3 mg/kg every 3 weeks

Reporting group title

Part 1B: BMS-986218 70 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 70 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 1B: BMS-986218 40 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 1B: BMS-986218 20 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 20 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 1B: BMS-986218 7 mg + Nivo 480 mg

Reporting group description

Participants received BMS-986218 at 7 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 2C: BMS-986218 + Nivo NSCLC

Reporting group description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Reporting group title

Part 2B: BMS-986218 70 mg NSCLC

Reporting group description

Participants received BMS-986218 at 70 mg every 4 weeks

Reporting group title

Part 2B: BMS-986218 20 mg NSCLC

Reporting group description

Participants received BMS-986218 at 20 mg every 4 weeks

Reporting group title

Part 2B: BMS-986218 7 mg NSCLC

Reporting group description

Participants received BMS-986218 at 7 mg every 4 weeks

Reporting group title

Part 2A: BMS-986218 70 mg Cutaneous Melanoma

Reporting group description

Participants received BMS-986218 at 70 mg every 4 weeks

Reporting group title

Part 2A: BMS-986218 20 mg Cutaneous Melanoma

Reporting group description

Participants received BMS-986218 at 20 mg every 4 weeks

Reporting group title

Part 2D: BMS-986218 + Nivo MSS CRC

Reporting group description

Participants received BMS-986218 at 40 mg with nivolumab at 480 mg every 4 weeks

Part 1A: BMS-986218 70 mg

Part 1A: BMS-986218 40 mg

Part 1A: BMS-986218 20 mg

Part 1A: BMS-986218 7 mg

Part 1A: BMS-986218 4 mg

Part 1A: BMS-986218 2 mg

Part 1A: BMS-986218 50 mg

Part 1A: BMS-986218 35 mg

Part 1A: BMS-986218 20 mg

Part 1A: BMS-986218 200 mg

Part 1A: BMS-986218 150 mg

Part 1A: BMS-986218 100 mg

Part 1A: BMS-986218 20 mg PD

Part 2A: BMS-986218 7 mg Cutaneous Melanoma

Part 2A: Ipilimumab Cutaneous Melanoma

Part 1B: BMS-986218 70 mg + Nivo 480 mg

Part 1B: BMS-986218 40 mg + Nivo 480 mg

Part 1B: BMS-986218 20 mg + Nivo 480 mg

Part 1B: BMS-986218 7 mg + Nivo 480 mg

Part 2C: BMS-986218 + Nivo NSCLC

Part 2B: BMS-986218 70 mg NSCLC

Part 2B: BMS-986218 20 mg NSCLC

Part 2B: BMS-986218 7 mg NSCLC

Part 2A: BMS-986218 70 mg Cutaneous Melanoma

Part 2A: BMS-986218 20 mg Cutaneous Melanoma

Part 2D: BMS-986218 + Nivo MSS CRC

Total subjects affected by serious adverse events

subjects affected / exposed

7 / 14 (50.00%)

10 / 12 (83.33%)

9 / 15 (60.00%)

5 / 12 (41.67%)

5 / 9 (55.56%)

2 / 4 (50.00%)

3 / 4 (75.00%)

4 / 6 (66.67%)

10 / 14 (71.43%)

5 / 5 (100.00%)

7 / 11 (63.64%)

5 / 7 (71.43%)

1 / 1 (100.00%)

11 / 19 (57.89%)

9 / 20 (45.00%)

7 / 7 (100.00%)

18 / 19 (94.74%)

13 / 17 (76.47%)

3 / 5 (60.00%)

23 / 29 (79.31%)

17 / 22 (77.27%)

15 / 22 (68.18%)

16 / 22 (72.73%)

12 / 18 (66.67%)

34 / 44 (77.27%)

number of deaths (all causes)

number of deaths resulting from adverse events

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

Cancer pain

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

1 / 19 (5.26%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 18 (5.56%)

0 / 44 (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

Malignant neoplasm progression

subjects affected / exposed

2 / 14 (14.29%)

3 / 12 (25.00%)

2 / 15 (13.33%)

1 / 12 (8.33%)

2 / 9 (22.22%)

0 / 4 (0.00%)

1 / 4 (25.00%)

3 / 6 (50.00%)

6 / 14 (42.86%)

1 / 5 (20.00%)

4 / 11 (36.36%)

2 / 7 (28.57%)

0 / 1 (0.00%)

3 / 19 (15.79%)

1 / 20 (5.00%)

2 / 7 (28.57%)

8 / 19 (42.11%)

8 / 17 (47.06%)

2 / 5 (40.00%)

10 / 29 (34.48%)

3 / 22 (13.64%)

9 / 22 (40.91%)

8 / 22 (36.36%)

6 / 18 (33.33%)

13 / 44 (29.55%)

occurrences causally related to treatment / all

0 / 2

0 / 3

0 / 2

0 / 1

0 / 2

0 / 0

0 / 1

0 / 4

0 / 6

0 / 1

0 / 4

0 / 2

0 / 0

0 / 3

0 / 1

0 / 2

0 / 8

0 / 2

0 / 10

0 / 3

0 / 9

0 / 8

0 / 6

0 / 13

deaths causally related to treatment / all

0 / 2

0 / 3

0 / 2

0 / 1

0 / 2

0 / 0

0 / 1

0 / 3

0 / 6

0 / 0

0 / 4

0 / 1

0 / 0

0 / 3

0 / 1

0 / 2

0 / 8

0 / 7

0 / 2

0 / 10

0 / 3

0 / 8

0 / 5

0 / 11

Metastases to bone

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Metastases to lung

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Metastases to central nervous system

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

1 / 15 (6.67%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Tumour fistulisation

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

1 / 19 (5.26%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neoplasm progression

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

1 / 15 (6.67%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

1 / 19 (5.26%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

1 / 17 (5.88%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

Tumour haemorrhage

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

1 / 20 (5.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Tumour necrosis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular disorders

Embolism

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Hypotension

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Peripheral artery thrombosis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

General disorders and administration site conditions

Asthenia

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

1 / 9 (11.11%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 18 (5.56%)

0 / 18 (0.00%)

0 / 44 (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

Chest pain

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Death

subjects affected / exposed

1 / 14 (7.14%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

2 / 29 (6.90%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

Fatigue

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

1 / 18 (5.56%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

General physical health deterioration

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 18 (5.56%)

0 / 44 (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

Localised oedema

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Malaise

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Non-cardiac chest pain

subjects affected / exposed

1 / 14 (7.14%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Multiple organ dysfunction syndrome

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pyrexia

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

1 / 4 (25.00%)

1 / 6 (16.67%)

0 / 14 (0.00%)

1 / 5 (20.00%)

1 / 11 (9.09%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 7 (14.29%)

2 / 19 (10.53%)

1 / 17 (5.88%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 18 (5.56%)

5 / 44 (11.36%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 1

0 / 1

0 / 0

0 / 1

1 / 1

0 / 0

1 / 1

1 / 2

0 / 1

0 / 0

1 / 1

1 / 5

deaths causally related to treatment / all

0 / 0

Pain

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Immune system disorders

Sarcoidosis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 7 (14.29%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Respiratory, thoracic and mediastinal disorders

Acute respiratory failure

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Dyspnoea

subjects affected / exposed

1 / 14 (7.14%)

0 / 12 (0.00%)

1 / 15 (6.67%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

3 / 29 (10.34%)

0 / 22 (0.00%)

2 / 22 (9.09%)

1 / 18 (5.56%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

0 / 1

0 / 0

0 / 3

0 / 0

0 / 3

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Haemoptysis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypoxia

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pleural effusion

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

1 / 15 (6.67%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 6 (0.00%)

2 / 14 (14.29%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

1 / 17 (5.88%)

1 / 5 (20.00%)

1 / 29 (3.45%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 2

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

1 / 1

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Pneumonitis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

1 / 11 (9.09%)

1 / 7 (14.29%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

1 / 1

0 / 0

Pneumothorax

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pulmonary embolism

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 18 (0.00%)

0 / 44 (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

0 / 1

0 / 0

Pulmonary oedema

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Respiratory failure

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

2 / 29 (6.90%)

1 / 22 (4.55%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

Psychiatric disorders

Delirium

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

1 / 20 (5.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Product issues

Device dislocation

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Investigations

Bilirubin conjugated increased

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Blood alkaline phosphatase increased

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

1 / 15 (6.67%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

3 / 14 (21.43%)

0 / 12 (0.00%)

1 / 15 (6.67%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

1 / 5 (20.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 4

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 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 18 (5.56%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Ejection fraction decreased

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Lipase increased

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

1 / 9 (11.11%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Platelet count decreased

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Troponin I increased

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

1 / 15 (6.67%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Troponin T increased

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Troponin increased

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Injury, poisoning and procedural complications

Hip fracture

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Overdose

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Rib fracture

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Spinal fracture

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Stoma prolapse

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Stoma site haemorrhage

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Thoracic vertebral fracture

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Toxicity to various agents

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cardiac disorders

Acute coronary syndrome

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

1 / 19 (5.26%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Angina pectoris

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

1 / 15 (6.67%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

1 / 19 (5.26%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 18 (5.56%)

0 / 44 (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

0 / 1

0 / 0

Cardiogenic shock

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

1 / 19 (5.26%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Immune-mediated myocarditis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

2 / 2

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Myocarditis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 18 (5.56%)

0 / 44 (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

Sinus tachycardia

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Supraventricular tachycardia

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Intracranial tumour haemorrhage

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 18 (5.56%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Aphasia

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Dizziness

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Haemorrhage intracranial

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haemorrhagic stroke

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 18 (5.56%)

0 / 18 (0.00%)

0 / 44 (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

Hepatic encephalopathy

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Immune-mediated encephalitis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

1 / 6 (16.67%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Intracranial pressure increased

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 18 (5.56%)

0 / 18 (0.00%)

0 / 44 (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

Ischaemic stroke

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 18 (5.56%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Spinal cord compression

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

1 / 15 (6.67%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Blood and lymphatic system disorders

Anaemia

subjects affected / exposed

1 / 14 (7.14%)

2 / 12 (16.67%)

1 / 15 (6.67%)

0 / 12 (0.00%)

1 / 9 (11.11%)

0 / 4 (0.00%)

1 / 6 (16.67%)

1 / 14 (7.14%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

2 / 19 (10.53%)

2 / 20 (10.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

2 / 44 (4.55%)

occurrences causally related to treatment / all

0 / 1

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

Febrile neutropenia

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Neutropenia

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Thrombocytopenia

subjects affected / exposed

1 / 14 (7.14%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Eye disorders

Vision blurred

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

1 / 1 (100.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal disorders

Abdominal pain

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

1 / 15 (6.67%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

1 / 6 (16.67%)

2 / 14 (14.29%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Ascites

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

2 / 44 (4.55%)

occurrences causally related to treatment / all

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

Colitis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

1 / 15 (6.67%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

1 / 7 (14.29%)

0 / 1 (0.00%)

1 / 19 (5.26%)

1 / 20 (5.00%)

1 / 7 (14.29%)

1 / 19 (5.26%)

1 / 17 (5.88%)

0 / 5 (0.00%)

5 / 29 (17.24%)

2 / 22 (9.09%)

0 / 22 (0.00%)

1 / 18 (5.56%)

0 / 18 (0.00%)

2 / 44 (4.55%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

1 / 1

2 / 2

0 / 0

6 / 6

2 / 2

0 / 0

1 / 1

0 / 0

2 / 2

deaths causally related to treatment / all

0 / 0

1 / 1

0 / 0

Constipation

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diarrhoea

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

1 / 15 (6.67%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

1 / 19 (5.26%)

1 / 20 (5.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

1 / 17 (5.88%)

0 / 5 (0.00%)

0 / 29 (0.00%)

3 / 22 (13.64%)

0 / 22 (0.00%)

1 / 18 (5.56%)

2 / 18 (11.11%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

4 / 5

0 / 0

1 / 1

2 / 2

1 / 1

deaths causally related to treatment / all

0 / 0

Duodenal obstruction

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

1 / 9 (11.11%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Duodenitis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Dysphagia

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Gastritis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Gastrointestinal haemorrhage

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

1 / 15 (6.67%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 18 (5.56%)

0 / 44 (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

Ileus

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

2 / 44 (4.55%)

occurrences causally related to treatment / all

0 / 0

0 / 3

deaths causally related to treatment / all

0 / 0

Immune-mediated enterocolitis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

1 / 20 (5.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

5 / 22 (22.73%)

2 / 22 (9.09%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 18 (5.56%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

0 / 0

1 / 1

5 / 5

2 / 2

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Impaired gastric emptying

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

1 / 15 (6.67%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Inguinal hernia, obstructive

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Intestinal obstruction

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 18 (5.56%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Intestinal perforation

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

Nausea

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Obstruction gastric

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Oesophageal obstruction

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pancreatic mass

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Pancreatitis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

1 / 19 (5.26%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Stomatitis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Upper gastrointestinal haemorrhage

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

1 / 9 (11.11%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Vomiting

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Malignant ascites

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

1 / 20 (5.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Hepatobiliary disorders

Biliary obstruction

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

1 / 15 (6.67%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cholangitis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Cholangitis acute

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

2 / 19 (10.53%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Hepatitis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

1 / 17 (5.88%)

0 / 5 (0.00%)

0 / 29 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

0 / 1

0 / 0

2 / 2

deaths causally related to treatment / all

0 / 0

Hypertransaminasaemia

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Immune-mediated cholangitis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

1 / 1

deaths causally related to treatment / all

0 / 0

Skin and subcutaneous tissue disorders

Rash maculo-papular

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Renal and urinary disorders

Acute kidney injury

subjects affected / exposed

1 / 14 (7.14%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 18 (5.56%)

0 / 18 (0.00%)

2 / 44 (4.55%)

occurrences causally related to treatment / all

1 / 1

0 / 0

0 / 1

0 / 0

1 / 2

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

Renal failure

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 18 (0.00%)

0 / 44 (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

Urinary retention

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Urinary tract obstruction

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

1 / 17 (5.88%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Endocrine disorders

Adrenal insufficiency

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypophysitis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

1 / 14 (7.14%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Inappropriate antidiuretic hormone secretion

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Musculoskeletal and connective tissue disorders

Arthralgia

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Back pain

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

1 / 4 (25.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Flank pain

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

deaths causally related to treatment / all

0 / 0

Lumbar spinal stenosis

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Muscular weakness

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Myositis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pain in extremity

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pathological fracture

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Abscess soft tissue

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bacteraemia

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 7 (14.29%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 4

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Bacterial sepsis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Biliary sepsis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Biliary tract infection

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

2 / 19 (10.53%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

COVID-19

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

1 / 7 (14.29%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

1 / 22 (4.55%)

1 / 18 (5.56%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

COVID-19 pneumonia

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

1 / 20 (5.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 18 (5.56%)

0 / 44 (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

Clostridium difficile colitis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

1 / 11 (9.09%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Cellulitis

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Conjunctivitis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 5 (20.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

1 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Device related infection

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

1 / 19 (5.26%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Diverticulitis intestinal perforated

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Endocarditis

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Gastroenteritis yersinia

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Haematological infection

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

1 / 17 (5.88%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Herpes zoster

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Infection

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Infectious pleural effusion

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

1 / 11 (9.09%)

0 / 7 (0.00%)

0 / 1 (0.00%)

1 / 19 (5.26%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Influenza

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Norovirus infection

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 18 (5.56%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Pneumonia

subjects affected / exposed

0 / 14 (0.00%)

2 / 12 (16.67%)

0 / 15 (0.00%)

1 / 12 (8.33%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

3 / 11 (27.27%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

4 / 22 (18.18%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 3

0 / 0

0 / 1

0 / 0

0 / 3

0 / 0

0 / 1

0 / 4

0 / 0

0 / 1

0 / 0

0 / 2

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

Pneumonia aspiration

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 18 (0.00%)

0 / 44 (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

Respiratory tract infection

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

1 / 18 (5.56%)

0 / 18 (0.00%)

0 / 44 (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

0 / 1

0 / 0

Sepsis

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

1 / 9 (11.11%)

0 / 4 (0.00%)

1 / 6 (16.67%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

1 / 20 (5.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

1 / 29 (3.45%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

0 / 0

Sinusitis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Septic shock

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 18 (0.00%)

0 / 44 (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

1 / 14 (7.14%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 7 (14.29%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 2

0 / 10

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Urinary tract infection staphylococcal

subjects affected / exposed

0 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 2

0 / 0

deaths causally related to treatment / all

0 / 0

Vascular device infection

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

1 / 11 (9.09%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

Dehydration

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

1 / 6 (16.67%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

3 / 44 (6.82%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

1 / 3

deaths causally related to treatment / all

0 / 0

Diabetic ketoacidosis

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

1 / 44 (2.27%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

0 / 1

deaths causally related to treatment / all

0 / 0

Failure to thrive

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

1 / 7 (14.29%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypercalcaemia

subjects affected / exposed

1 / 14 (7.14%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

2 / 19 (10.53%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

1 / 22 (4.55%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 1

0 / 0

0 / 2

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypercreatininaemia

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

1 / 4 (25.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (0.00%)

occurrences causally related to treatment / all

0 / 0

0 / 1

0 / 0

deaths causally related to treatment / all

0 / 0

Hypokalaemia

subjects affected / exposed

0 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

1 / 19 (5.26%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

0 / 17 (0.00%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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 / 14 (0.00%)

0 / 12 (0.00%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

1 / 5 (20.00%)

1 / 11 (9.09%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

1 / 17 (5.88%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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 / 14 (0.00%)

1 / 12 (8.33%)

0 / 15 (0.00%)

0 / 12 (0.00%)

0 / 9 (0.00%)

0 / 4 (0.00%)

0 / 6 (0.00%)

0 / 14 (0.00%)

0 / 5 (0.00%)

0 / 11 (0.00%)

0 / 7 (0.00%)

0 / 1 (0.00%)

0 / 19 (0.00%)

0 / 20 (0.00%)

0 / 7 (0.00%)

0 / 19 (0.00%)

1 / 17 (5.88%)

0 / 5 (0.00%)

0 / 29 (0.00%)

0 / 22 (0.00%)

0 / 18 (0.00%)

0 / 44 (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

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

Non-serious adverse events	Part 1A: BMS-986218 70 mg	Part 1A: BMS-986218 40 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 7 mg	Part 1A: BMS-986218 4 mg	Part 1A: BMS-986218 2 mg	Part 1A: BMS-986218 50 mg	Part 1A: BMS-986218 35 mg	Part 1A: BMS-986218 20 mg	Part 1A: BMS-986218 200 mg	Part 1A: BMS-986218 150 mg	Part 1A: BMS-986218 100 mg	Part 1A: BMS-986218 20 mg PD	Part 2A: BMS-986218 7 mg Cutaneous Melanoma	Part 2A: Ipilimumab Cutaneous Melanoma	Part 1B: BMS-986218 70 mg + Nivo 480 mg	Part 1B: BMS-986218 40 mg + Nivo 480 mg	Part 1B: BMS-986218 20 mg + Nivo 480 mg	Part 1B: BMS-986218 7 mg + Nivo 480 mg	Part 2C: BMS-986218 + Nivo NSCLC	Part 2B: BMS-986218 70 mg NSCLC	Part 2B: BMS-986218 20 mg NSCLC	Part 2B: BMS-986218 7 mg NSCLC	Part 2A: BMS-986218 70 mg Cutaneous Melanoma	Part 2A: BMS-986218 20 mg Cutaneous Melanoma	Part 2D: BMS-986218 + Nivo MSS CRC
Total subjects affected by non serious adverse events
subjects affected / exposed	14 / 14 (100.00%)	11 / 12 (91.67%)	15 / 15 (100.00%)	11 / 12 (91.67%)	9 / 9 (100.00%)	4 / 4 (100.00%)	4 / 4 (100.00%)	5 / 6 (83.33%)	13 / 14 (92.86%)	5 / 5 (100.00%)	11 / 11 (100.00%)	7 / 7 (100.00%)	1 / 1 (100.00%)	19 / 19 (100.00%)	18 / 20 (90.00%)	7 / 7 (100.00%)	19 / 19 (100.00%)	16 / 17 (94.12%)	5 / 5 (100.00%)	27 / 29 (93.10%)	21 / 22 (95.45%)	21 / 22 (95.45%)	21 / 22 (95.45%)	16 / 18 (88.89%)	15 / 18 (83.33%)	43 / 44 (97.73%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	2 / 19 (10.53%)	2 / 20 (10.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	2 / 22 (9.09%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0	0	2	2	0	1	0	0	0	0	0	2	0	1	0
Malignant neoplasm progression
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	1
Tumour associated fever
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Metastases to central nervous system
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Tumour pain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	2 / 19 (10.53%)	0 / 17 (0.00%)	1 / 5 (20.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	2 / 18 (11.11%)	0 / 44 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	1	0	0	1	0	0	2	0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	1	0	0	0	1	0	0	0	1	0	1	0	0	1	0	0	0	0	0	1	0	0	1	0	0	2
Aortic stenosis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Flushing
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	2	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Hypertension
subjects affected / exposed	1 / 14 (7.14%)	2 / 12 (16.67%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	2 / 19 (10.53%)	0 / 17 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	2 / 22 (9.09%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	1 / 18 (5.56%)	1 / 44 (2.27%)
occurrences all number	1	6	0	0	0	0	0	0	0	0	0	0	0	0	1	0	4	0	0	2	2	0	0	1	1	1
Hot flush
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Haematoma
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Hypotension
subjects affected / exposed	1 / 14 (7.14%)	2 / 12 (16.67%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 6 (33.33%)	2 / 14 (14.29%)	1 / 5 (20.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 7 (14.29%)	5 / 19 (26.32%)	0 / 17 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	3 / 22 (13.64%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	3 / 44 (6.82%)
occurrences all number	1	2	0	0	0	0	0	2	2	3	1	1	0	0	1	1	5	0	0	2	3	0	0	0	0	4
Jugular vein thrombosis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Lymphoedema
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1
Subclavian vein thrombosis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Superficial vein thrombosis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Vasculitis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Vena cava thrombosis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 6 (16.67%)	1 / 14 (7.14%)	1 / 5 (20.00%)	2 / 11 (18.18%)	1 / 7 (14.29%)	0 / 1 (0.00%)	3 / 19 (15.79%)	5 / 20 (25.00%)	0 / 7 (0.00%)	6 / 19 (31.58%)	1 / 17 (5.88%)	1 / 5 (20.00%)	3 / 29 (10.34%)	4 / 22 (18.18%)	1 / 22 (4.55%)	2 / 22 (9.09%)	2 / 18 (11.11%)	2 / 18 (11.11%)	8 / 44 (18.18%)
occurrences all number	0	1	1	0	0	0	1	1	1	1	2	1	0	3	5	0	7	1	1	3	6	1	2	2	2	8
Axillary pain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Chills
subjects affected / exposed	1 / 14 (7.14%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	2 / 7 (28.57%)	2 / 19 (10.53%)	2 / 17 (11.76%)	0 / 5 (0.00%)	3 / 29 (10.34%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	3	0	0	0	0	0	0	0	0	0	0	0	0	0	2	3	2	0	3	0	0	0	1	0	0
Face oedema
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Gait disturbance
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	1	0	1
Fatigue
subjects affected / exposed	7 / 14 (50.00%)	3 / 12 (25.00%)	6 / 15 (40.00%)	2 / 12 (16.67%)	3 / 9 (33.33%)	1 / 4 (25.00%)	0 / 4 (0.00%)	3 / 6 (50.00%)	5 / 14 (35.71%)	1 / 5 (20.00%)	7 / 11 (63.64%)	3 / 7 (42.86%)	0 / 1 (0.00%)	6 / 19 (31.58%)	3 / 20 (15.00%)	5 / 7 (71.43%)	9 / 19 (47.37%)	9 / 17 (52.94%)	1 / 5 (20.00%)	12 / 29 (41.38%)	10 / 22 (45.45%)	11 / 22 (50.00%)	5 / 22 (22.73%)	4 / 18 (22.22%)	7 / 18 (38.89%)	19 / 44 (43.18%)
occurrences all number	7	4	6	3	3	1	0	3	5	1	7	3	0	6	4	5	9	9	1	12	13	17	5	5	8	21
Influenza like illness
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	4
Injection site rash
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Infusion site extravasation
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Localised oedema
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Mucosal inflammation
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	2	1	0	0	2	0	0	0	0	0	0
Malaise
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0
Non-cardiac chest pain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	2 / 22 (9.09%)	3 / 22 (13.64%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	1	1	0	0	1	0	1	1	0	1	0	0	1	0	0	1	1	2	3	0	0	1
Pain
subjects affected / exposed	0 / 14 (0.00%)	2 / 12 (16.67%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	0	2	1	0	0	0	0	0	1	0	0	1	0	0	0	0	1	1	0	0	0	0	0	1	0	2
Oedema peripheral
subjects affected / exposed	1 / 14 (7.14%)	3 / 12 (25.00%)	3 / 15 (20.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	4 / 14 (28.57%)	2 / 5 (40.00%)	4 / 11 (36.36%)	1 / 7 (14.29%)	0 / 1 (0.00%)	1 / 19 (5.26%)	2 / 20 (10.00%)	3 / 7 (42.86%)	2 / 19 (10.53%)	2 / 17 (11.76%)	1 / 5 (20.00%)	4 / 29 (13.79%)	1 / 22 (4.55%)	0 / 22 (0.00%)	4 / 22 (18.18%)	1 / 18 (5.56%)	0 / 18 (0.00%)	5 / 44 (11.36%)
occurrences all number	3	3	3	1	0	0	0	1	4	2	4	1	0	1	2	3	2	2	1	4	1	0	4	1	0	5
Peripheral swelling
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	1	0	0
Pyrexia
subjects affected / exposed	2 / 14 (14.29%)	3 / 12 (25.00%)	4 / 15 (26.67%)	1 / 12 (8.33%)	0 / 9 (0.00%)	1 / 4 (25.00%)	2 / 4 (50.00%)	2 / 6 (33.33%)	0 / 14 (0.00%)	3 / 5 (60.00%)	4 / 11 (36.36%)	1 / 7 (14.29%)	0 / 1 (0.00%)	2 / 19 (10.53%)	2 / 20 (10.00%)	4 / 7 (57.14%)	9 / 19 (47.37%)	2 / 17 (11.76%)	0 / 5 (0.00%)	4 / 29 (13.79%)	6 / 22 (27.27%)	2 / 22 (9.09%)	0 / 22 (0.00%)	3 / 18 (16.67%)	1 / 18 (5.56%)	19 / 44 (43.18%)
occurrences all number	2	4	4	1	0	1	3	3	0	5	6	2	0	2	2	7	14	3	0	7	9	2	0	3	1	28
Xerosis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	1	2	1	0	0	0	1
Immune system disorders
Rubber sensitivity
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Sarcoidosis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Reproductive system and breast disorders
Breast oedema
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0	0
Oedema genital
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Pelvic haemorrhage
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Perineal pain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Testicular disorder
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (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	0	0	0	0	0	0
Testicular oedema
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Vaginal discharge
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Vaginal haemorrhage
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	2	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Malignant pleural effusion
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Atelectasis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Bronchospasm
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	2	0	0
Dysphonia
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	1	0	0	0
Cough
subjects affected / exposed	2 / 14 (14.29%)	2 / 12 (16.67%)	3 / 15 (20.00%)	0 / 12 (0.00%)	2 / 9 (22.22%)	2 / 4 (50.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	3 / 11 (27.27%)	0 / 7 (0.00%)	0 / 1 (0.00%)	3 / 19 (15.79%)	1 / 20 (5.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	2 / 17 (11.76%)	0 / 5 (0.00%)	6 / 29 (20.69%)	6 / 22 (27.27%)	5 / 22 (22.73%)	3 / 22 (13.64%)	1 / 18 (5.56%)	1 / 18 (5.56%)	11 / 44 (25.00%)
occurrences all number	2	2	3	0	2	2	0	0	1	0	3	0	0	3	1	0	1	2	0	7	6	5	3	1	1	12
Dyspnoea
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	1 / 12 (8.33%)	3 / 9 (33.33%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	3 / 14 (21.43%)	1 / 5 (20.00%)	4 / 11 (36.36%)	3 / 7 (42.86%)	0 / 1 (0.00%)	2 / 19 (10.53%)	1 / 20 (5.00%)	0 / 7 (0.00%)	4 / 19 (21.05%)	2 / 17 (11.76%)	2 / 5 (40.00%)	6 / 29 (20.69%)	6 / 22 (27.27%)	7 / 22 (31.82%)	7 / 22 (31.82%)	3 / 18 (16.67%)	0 / 18 (0.00%)	8 / 44 (18.18%)
occurrences all number	0	1	1	1	3	1	0	0	3	1	5	3	0	2	1	0	5	2	2	6	6	7	9	4	0	9
Dyspnoea exertional
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Haemoptysis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	2 / 22 (9.09%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	2	0	0	0	0	0	0	0	0	1	2	1	1	0	0	0
Hypoxia
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	3 / 29 (10.34%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	1	0	1	0	0	0	0	0	1	0	0	4	0	1	0	0	0	0
Hiccups
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	2 / 29 (6.90%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	2	2	1	0	0	0	0
Oropharyngeal pain
subjects affected / exposed	2 / 14 (14.29%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	2	1	0	0	0	0	0	0	0	2	1	1	0	1	0	0	0	0	0	0	1	0	0	0	0	0
Nasal congestion
subjects affected / exposed	0 / 14 (0.00%)	3 / 12 (25.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	3	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Pleural effusion
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	2 / 17 (11.76%)	0 / 5 (0.00%)	2 / 29 (6.90%)	0 / 22 (0.00%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	1	1	0	0	0	0	1	0	0	2	0	0	0	0	0	0	2	0	2	0	2	1	0	0	1
Pleuritic pain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	1	1	1	1	0	0	0
Productive cough
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	2 / 22 (9.09%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	1	2	2	1	0	0	2
Pneumonitis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	2 / 22 (9.09%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	1	0	1	0	0	1	0	0	2	0	2	0	0	1	0
Pulmonary embolism
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	1	0	0	0	0	2
Rhinitis allergic
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	1
Rhinorrhoea
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0
Sinus congestion
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Wheezing
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	1	0	0	0	0
Upper-airway cough syndrome
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Psychiatric disorders
Agitation
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Anxiety
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	0 / 5 (0.00%)	2 / 11 (18.18%)	1 / 7 (14.29%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	2	0	2	1	0	1	0	1	0	0	0	1	1	1	0	0	0	0
Confusional state
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	1	0	0	1	1	1	0	0	1	0
Depression
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	3 / 11 (27.27%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	3	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Insomnia
subjects affected / exposed	1 / 14 (7.14%)	1 / 12 (8.33%)	0 / 15 (0.00%)	1 / 12 (8.33%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	1 / 5 (20.00%)	3 / 11 (27.27%)	1 / 7 (14.29%)	0 / 1 (0.00%)	1 / 19 (5.26%)	3 / 20 (15.00%)	2 / 7 (28.57%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	3 / 29 (10.34%)	2 / 22 (9.09%)	4 / 22 (18.18%)	1 / 22 (4.55%)	1 / 18 (5.56%)	0 / 18 (0.00%)	4 / 44 (9.09%)
occurrences all number	1	1	0	1	1	0	0	1	0	1	3	1	0	1	3	2	0	1	0	3	2	4	1	1	0	4
Irritability
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Persistent depressive disorder
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Investigations
Activated partial thromboplastin time prolonged
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0
Alanine aminotransferase increased
subjects affected / exposed	2 / 14 (14.29%)	1 / 12 (8.33%)	2 / 15 (13.33%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	3 / 14 (21.43%)	0 / 5 (0.00%)	2 / 11 (18.18%)	1 / 7 (14.29%)	0 / 1 (0.00%)	2 / 19 (10.53%)	4 / 20 (20.00%)	3 / 7 (42.86%)	5 / 19 (26.32%)	1 / 17 (5.88%)	0 / 5 (0.00%)	4 / 29 (13.79%)	3 / 22 (13.64%)	5 / 22 (22.73%)	1 / 22 (4.55%)	3 / 18 (16.67%)	3 / 18 (16.67%)	14 / 44 (31.82%)
occurrences all number	2	1	2	0	0	1	0	1	3	0	2	2	0	3	5	3	6	1	0	7	5	5	2	3	6	21
Aspartate aminotransferase increased
subjects affected / exposed	2 / 14 (14.29%)	2 / 12 (16.67%)	2 / 15 (13.33%)	1 / 12 (8.33%)	0 / 9 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	3 / 14 (21.43%)	1 / 5 (20.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 1 (0.00%)	4 / 19 (21.05%)	3 / 20 (15.00%)	4 / 7 (57.14%)	7 / 19 (36.84%)	2 / 17 (11.76%)	2 / 5 (40.00%)	5 / 29 (17.24%)	3 / 22 (13.64%)	4 / 22 (18.18%)	1 / 22 (4.55%)	2 / 18 (11.11%)	3 / 18 (16.67%)	12 / 44 (27.27%)
occurrences all number	2	2	2	1	0	1	0	1	3	1	1	2	0	6	4	5	9	3	2	8	6	5	2	2	3	16
Amylase increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	4 / 19 (21.05%)	1 / 20 (5.00%)	2 / 7 (28.57%)	2 / 19 (10.53%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	2 / 22 (9.09%)	2 / 22 (9.09%)	1 / 22 (4.55%)	3 / 18 (16.67%)	1 / 18 (5.56%)	6 / 44 (13.64%)
occurrences all number	0	0	0	0	1	3	0	0	0	0	0	0	0	5	2	3	2	0	0	1	2	2	1	5	2	7
Bilirubin conjugated increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0
Blood alkaline phosphatase increased
subjects affected / exposed	3 / 14 (21.43%)	0 / 12 (0.00%)	2 / 15 (13.33%)	0 / 12 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	2 / 5 (40.00%)	2 / 11 (18.18%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	2 / 20 (10.00%)	1 / 7 (14.29%)	2 / 19 (10.53%)	2 / 17 (11.76%)	1 / 5 (20.00%)	2 / 29 (6.90%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	1 / 18 (5.56%)	6 / 44 (13.64%)
occurrences all number	3	0	2	0	1	1	0	0	4	2	2	0	0	1	2	1	2	2	1	2	2	0	0	1	1	8
Blood albumin decreased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	2 / 19 (10.53%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	2 / 29 (6.90%)	1 / 22 (4.55%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 18 (0.00%)	2 / 18 (11.11%)	4 / 44 (9.09%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	1	0	2	4	2	1	0	3	4
Blood bilirubin increased
subjects affected / exposed	3 / 14 (21.43%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	2 / 6 (33.33%)	2 / 14 (14.29%)	1 / 5 (20.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	2 / 19 (10.53%)	1 / 20 (5.00%)	2 / 7 (28.57%)	3 / 19 (15.79%)	1 / 17 (5.88%)	1 / 5 (20.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 22 (0.00%)	2 / 18 (11.11%)	1 / 18 (5.56%)	12 / 44 (27.27%)
occurrences all number	4	1	1	0	0	1	0	2	2	1	1	0	0	6	2	2	4	1	1	2	1	1	0	4	1	13
Blood calcium decreased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 18 (0.00%)	1 / 18 (5.56%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	2	1	1	0	1	1
Blood calcium increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	3 / 44 (6.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	3
Blood cholesterol increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	2 / 19 (10.53%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	1	0	2
Blood creatine phosphokinase increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	2 / 19 (10.53%)	2 / 20 (10.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	2 / 18 (11.11%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	2	2	0	0	0	0	3	0	1	0	0	3	1
Blood creatinine increased
subjects affected / exposed	0 / 14 (0.00%)	2 / 12 (16.67%)	0 / 15 (0.00%)	0 / 12 (0.00%)	3 / 9 (33.33%)	1 / 4 (25.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	3 / 20 (15.00%)	1 / 7 (14.29%)	2 / 19 (10.53%)	0 / 17 (0.00%)	1 / 5 (20.00%)	5 / 29 (17.24%)	1 / 22 (4.55%)	1 / 22 (4.55%)	2 / 22 (9.09%)	0 / 18 (0.00%)	4 / 18 (22.22%)	6 / 44 (13.64%)
occurrences all number	0	2	0	0	3	1	1	0	6	0	0	0	0	0	3	1	2	0	1	5	1	2	2	0	8	11
Blood fibrinogen decreased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Blood glucose increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	3 / 19 (15.79%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	2 / 22 (9.09%)	2 / 22 (9.09%)	0 / 18 (0.00%)	1 / 18 (5.56%)	3 / 44 (6.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	4	1	0	0	0	0	0	0	3	2	0	1	3
Blood lactate dehydrogenase increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Blood magnesium increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0
Blood magnesium decreased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	3 / 19 (15.79%)	2 / 20 (10.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	3 / 29 (10.34%)	2 / 22 (9.09%)	2 / 22 (9.09%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	6 / 44 (13.64%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	6	2	0	0	0	0	4	3	3	0	0	3	9
Blood phosphorus increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0
Blood potassium increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0
Blood potassium decreased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	2	2	0	0	0	0	0	0	0	0	0	0	4
Blood sodium decreased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	3 / 19 (15.79%)	2 / 20 (10.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	2 / 22 (9.09%)	0 / 18 (0.00%)	4 / 18 (22.22%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	3	4	0	0	0	0	0	0	0	3	0	8	0
Blood thyroid stimulating hormone decreased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0
Blood thyroid stimulating hormone increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	2 / 19 (10.53%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	4 / 44 (9.09%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	1	2	0	0	0	3	0	0	0	0	4
Blood triglycerides increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Blood uric acid increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
C-reactive protein increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	2 / 22 (9.09%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	2	2	2	1	0	0	0
Breath sounds abnormal
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Brain natriuretic peptide increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Body temperature increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	2 / 44 (4.55%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	1	2
Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	2 / 15 (13.33%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	1 / 5 (20.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	2 / 7 (28.57%)	0 / 19 (0.00%)	2 / 17 (11.76%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 22 (0.00%)	1 / 18 (5.56%)	1 / 18 (5.56%)	4 / 44 (9.09%)
occurrences all number	0	1	2	0	0	0	0	0	2	1	0	1	0	1	0	2	0	2	0	1	1	1	0	1	1	4
Fibrin D dimer increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Eosinophil count increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0
International normalised ratio increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	1	0	0	0	1	0	0	0	0	0	1
Eosinophil count decreased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Lymphocyte count decreased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	1 / 5 (20.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	3 / 7 (42.86%)	1 / 19 (5.26%)	1 / 17 (5.88%)	0 / 5 (0.00%)	2 / 29 (6.90%)	2 / 22 (9.09%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	0	0	0	1	0	0	0	0	3	1	0	1	0	0	0	4	1	1	0	4	2	0	1	0	0	6
Lipase increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	1 / 12 (8.33%)	0 / 9 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	4 / 19 (21.05%)	2 / 20 (10.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	1 / 5 (20.00%)	5 / 29 (17.24%)	3 / 22 (13.64%)	1 / 22 (4.55%)	2 / 22 (9.09%)	3 / 18 (16.67%)	1 / 18 (5.56%)	9 / 44 (20.45%)
occurrences all number	0	0	1	1	0	1	0	0	0	0	0	0	0	5	3	2	0	0	1	6	4	3	2	4	3	11
Neutrophil count decreased
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 7 (28.57%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Neutrophil count increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Platelet count decreased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	1 / 20 (5.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	3 / 44 (6.82%)
occurrences all number	0	0	0	0	0	1	0	0	1	0	0	0	0	4	1	1	0	2	0	0	1	0	0	0	0	6
Platelet count increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Troponin I increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	2 / 14 (14.29%)	0 / 5 (0.00%)	2 / 11 (18.18%)	1 / 7 (14.29%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	1 / 7 (14.29%)	2 / 19 (10.53%)	1 / 17 (5.88%)	0 / 5 (0.00%)	2 / 29 (6.90%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	2 / 44 (4.55%)
occurrences all number	0	0	0	0	0	0	0	1	3	0	2	1	0	1	0	1	2	1	0	3	1	1	0	0	1	2
Transaminases increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Troponin T increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 7 (28.57%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	1 / 17 (5.88%)	0 / 5 (0.00%)	2 / 29 (6.90%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	2	0	0	0	0	1	1	0	2	0	0	0	0	0	1
Viral test positive
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (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	0	0	0	0	0	0
Troponin increased
subjects affected / exposed	0 / 14 (0.00%)	2 / 12 (16.67%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	3 / 5 (60.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	2 / 19 (10.53%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	1 / 17 (5.88%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	2	3	0	1	0	2	0	0	1	1	0	1	1	0	1	0	0	0
Weight decreased
subjects affected / exposed	2 / 14 (14.29%)	3 / 12 (25.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 6 (33.33%)	1 / 14 (7.14%)	1 / 5 (20.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	2 / 7 (28.57%)	4 / 19 (21.05%)	7 / 17 (41.18%)	1 / 5 (20.00%)	2 / 29 (6.90%)	5 / 22 (22.73%)	1 / 22 (4.55%)	1 / 22 (4.55%)	2 / 18 (11.11%)	1 / 18 (5.56%)	5 / 44 (11.36%)
occurrences all number	2	3	0	0	0	0	0	2	1	1	1	1	0	1	0	2	5	7	1	2	6	1	1	2	1	7
White blood cell count decreased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	2 / 7 (28.57%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	2	0	1	0	0	0	0	0	0	0	0	0	0	1	0
Weight increased
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0
Injury, poisoning and procedural complications
Arthropod bite
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Clavicle fracture
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Ligament sprain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Infusion related reaction
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	3 / 19 (15.79%)	1 / 17 (5.88%)	1 / 5 (20.00%)	2 / 29 (6.90%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	1 / 18 (5.56%)	1 / 18 (5.56%)	6 / 44 (13.64%)
occurrences all number	0	0	1	0	0	1	0	0	0	0	1	0	0	0	0	1	4	1	1	2	0	1	0	1	1	6
Fall
subjects affected / exposed	0 / 14 (0.00%)	2 / 12 (16.67%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	3	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0
Contusion
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	1	0	0	0	0	1	0
Procedural pain
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	2 / 22 (9.09%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	0	0	0
Skin laceration
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Rib fracture
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Spinal fracture
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Thermal burn
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	2 / 22 (9.09%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0
Vascular access site erythema
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Vascular access site pain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Wound haemorrhage
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0
Atrial flutter
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Atrioventricular block first degree
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Bradycardia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Coronary artery disease
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Diastolic dysfunction
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Pericardial effusion
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0
Palpitations
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	1	0	0	0	0	0	0
Myocarditis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	1
Sinus bradycardia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Sinus tachycardia
subjects affected / exposed	1 / 14 (7.14%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	3 / 19 (15.79%)	1 / 17 (5.88%)	1 / 5 (20.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	1	1	0	0	0	0	0	0	1	0	0	0	0	0	0	0	3	1	1	0	0	1	1	0	0	2
Supraventricular tachycardia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Tachycardia
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	1 / 18 (5.56%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	2	0	0	1	1	0	1
Acute myocardial infarction
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Nervous system disorders
Intracranial tumour haemorrhage
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Cauda equina syndrome
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Dizziness
subjects affected / exposed	3 / 14 (21.43%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	2 / 18 (11.11%)	2 / 44 (4.55%)
occurrences all number	3	0	0	2	1	0	0	0	5	0	0	0	0	1	0	0	1	0	0	0	1	0	0	1	2	2
Dysarthria
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Dysgeusia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	1 / 7 (14.29%)	1 / 19 (5.26%)	1 / 17 (5.88%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	2 / 22 (9.09%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	2	0	0	1	0	1	1	1	0	1	0	2	0	0	0	2
Carpal tunnel syndrome
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Facial paralysis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (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	0	0	0	0	0	0
Hypoaesthesia
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1
Headache
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	1 / 11 (9.09%)	2 / 7 (28.57%)	0 / 1 (0.00%)	0 / 19 (0.00%)	2 / 20 (10.00%)	2 / 7 (28.57%)	3 / 19 (15.79%)	3 / 17 (17.65%)	1 / 5 (20.00%)	4 / 29 (13.79%)	1 / 22 (4.55%)	3 / 22 (13.64%)	3 / 22 (13.64%)	4 / 18 (22.22%)	2 / 18 (11.11%)	2 / 44 (4.55%)
occurrences all number	0	2	0	0	1	0	0	0	1	0	1	3	0	0	3	2	3	3	1	4	1	3	3	4	2	2
Haemorrhagic stroke
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Lethargy
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Memory impairment
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Neuralgia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Neuropathy peripheral
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (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	0	1	0	0	0	0
Paraesthesia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	1 / 22 (4.55%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	1	0	1	0	0	0
Peripheral sensory neuropathy
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0
Presyncope
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Seizure
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0
Somnolence
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	1 / 17 (5.88%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	1	0	1	1	0	0	0	0	1
Spinal cord compression
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (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	0	0	0	0	0	0
Tremor
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Syncope
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	1 / 22 (4.55%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	1	0	0
Sciatica
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	2 / 14 (14.29%)	4 / 12 (33.33%)	4 / 15 (26.67%)	3 / 12 (25.00%)	3 / 9 (33.33%)	1 / 4 (25.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	7 / 14 (50.00%)	4 / 5 (80.00%)	2 / 11 (18.18%)	3 / 7 (42.86%)	0 / 1 (0.00%)	8 / 19 (42.11%)	6 / 20 (30.00%)	6 / 7 (85.71%)	3 / 19 (15.79%)	4 / 17 (23.53%)	3 / 5 (60.00%)	9 / 29 (31.03%)	12 / 22 (54.55%)	4 / 22 (18.18%)	4 / 22 (18.18%)	3 / 18 (16.67%)	8 / 18 (44.44%)	20 / 44 (45.45%)
occurrences all number	2	4	6	3	3	1	0	2	7	5	3	5	0	10	7	7	5	4	3	11	19	7	6	4	11	24
Iron deficiency anaemia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Neutropenia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	3 / 19 (15.79%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	2 / 22 (9.09%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 18 (0.00%)	1 / 18 (5.56%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	0	0	0	3	0	0	0	0	0	1	3	0	1	0	1	1
Leukopenia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	2 / 19 (10.53%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	4	0	0	0	0	0	0	1	0	0	0	0	1
Leukocytosis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Thrombocytopenia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	2 / 20 (10.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	2 / 22 (9.09%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	0	0	0	1	2	0	0	0	0	0	0	0	2	0	0	1
Ear and labyrinth disorders
Vertigo
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	1 / 5 (20.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0
Hypoacusis
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Ear pain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0
Eye disorders
Blepharitis
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Dry eye
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Exophthalmos
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Eye haemorrhage
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Eye inflammation
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (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	0	0	0	0	0	0
Eye oedema
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Periorbital swelling
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Vision blurred
subjects affected / exposed	2 / 14 (14.29%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	2	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0
Vitreous floaters
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0	0	0
Abdominal distension
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	2 / 14 (14.29%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	2 / 20 (10.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	1	0	0	1	2	1	0	0	0	0	2	0	1	1	0	0	1	0	0	1	0	1
Abdominal pain lower
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Abdominal pain
subjects affected / exposed	2 / 14 (14.29%)	1 / 12 (8.33%)	2 / 15 (13.33%)	2 / 12 (16.67%)	2 / 9 (22.22%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 6 (16.67%)	5 / 14 (35.71%)	1 / 5 (20.00%)	3 / 11 (27.27%)	0 / 7 (0.00%)	0 / 1 (0.00%)	2 / 19 (10.53%)	2 / 20 (10.00%)	0 / 7 (0.00%)	4 / 19 (21.05%)	4 / 17 (23.53%)	0 / 5 (0.00%)	5 / 29 (17.24%)	5 / 22 (22.73%)	3 / 22 (13.64%)	1 / 22 (4.55%)	2 / 18 (11.11%)	2 / 18 (11.11%)	11 / 44 (25.00%)
occurrences all number	2	1	2	2	2	0	1	2	5	1	4	0	0	2	2	0	5	4	0	5	6	4	1	2	2	13
Abdominal pain upper
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	1 / 22 (4.55%)	1 / 18 (5.56%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	1	0	1	0	0	0	0	0	0	0	0	0	0	1	1	0	0	1	0	0	1	0	1	1	0	1
Anal incontinence
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0
Ascites
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	4 / 44 (9.09%)
occurrences all number	1	0	1	0	0	0	0	1	0	0	0	0	0	0	1	1	0	1	0	0	0	0	1	0	0	5
Colitis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	4 / 29 (13.79%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	5	1	0	0	1	1	0
Dry mouth
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 12 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	2 / 7 (28.57%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	0	1	1	0	1	1	1	0	0	0	0	1	0	0	0	2	0	0	0	1	0	0	0	0	0	2
Diarrhoea
subjects affected / exposed	3 / 14 (21.43%)	4 / 12 (33.33%)	5 / 15 (33.33%)	1 / 12 (8.33%)	1 / 9 (11.11%)	1 / 4 (25.00%)	3 / 4 (75.00%)	1 / 6 (16.67%)	4 / 14 (28.57%)	3 / 5 (60.00%)	3 / 11 (27.27%)	3 / 7 (42.86%)	0 / 1 (0.00%)	8 / 19 (42.11%)	7 / 20 (35.00%)	5 / 7 (71.43%)	5 / 19 (26.32%)	3 / 17 (17.65%)	0 / 5 (0.00%)	9 / 29 (31.03%)	9 / 22 (40.91%)	5 / 22 (22.73%)	3 / 22 (13.64%)	7 / 18 (38.89%)	4 / 18 (22.22%)	16 / 44 (36.36%)
occurrences all number	3	6	6	2	1	2	4	3	4	4	5	8	0	10	9	7	5	5	0	12	16	10	4	13	5	24
Constipation
subjects affected / exposed	2 / 14 (14.29%)	3 / 12 (25.00%)	4 / 15 (26.67%)	7 / 12 (58.33%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	7 / 14 (50.00%)	1 / 5 (20.00%)	2 / 11 (18.18%)	1 / 7 (14.29%)	0 / 1 (0.00%)	5 / 19 (26.32%)	1 / 20 (5.00%)	0 / 7 (0.00%)	3 / 19 (15.79%)	3 / 17 (17.65%)	2 / 5 (40.00%)	5 / 29 (17.24%)	2 / 22 (9.09%)	4 / 22 (18.18%)	1 / 22 (4.55%)	4 / 18 (22.22%)	4 / 18 (22.22%)	9 / 44 (20.45%)
occurrences all number	2	4	4	7	1	0	0	0	7	1	2	1	0	6	1	0	3	3	2	6	2	4	1	4	4	10
Dyspepsia
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	1	0	0	1	0	0	0	0	0	0	3	0	0	1	0	0	1	1	0	0	1	1	1	0	0	1
Dysphagia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	1 / 5 (20.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	0	1	0	0	1	0	0	0	0	1	0	1	1	0	0	0	0
Eructation
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	1 / 5 (20.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0	0
Flatulence
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 5 (20.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 1 (0.00%)	2 / 19 (10.53%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	3 / 44 (6.82%)
occurrences all number	0	0	0	1	0	0	0	0	1	1	1	1	0	2	0	1	0	0	0	1	0	1	0	0	0	3
Gastritis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Gastrointestinal pain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	1 / 5 (20.00%)	3 / 29 (10.34%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	1	0	0	1	1	0	0	1	1	3	0	0	0	0	0	0
Gingival pain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1
Gingival swelling
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Haematochezia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	2	0	0	0	0	0	0
Immune-mediated enterocolitis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	3 / 22 (13.64%)	2 / 22 (9.09%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	1	0	0	1	0	0	0	0	1	0	1	0	0	2	4	2	0	0	1	1
Ileus
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Haemorrhoids
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	2 / 44 (4.55%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	1	2
Inguinal hernia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Intra-abdominal haemorrhage
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Intestinal obstruction
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Irritable bowel syndrome
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Lip pain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Nausea
subjects affected / exposed	3 / 14 (21.43%)	0 / 12 (0.00%)	4 / 15 (26.67%)	0 / 12 (0.00%)	1 / 9 (11.11%)	2 / 4 (50.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	5 / 14 (35.71%)	3 / 5 (60.00%)	3 / 11 (27.27%)	2 / 7 (28.57%)	0 / 1 (0.00%)	5 / 19 (26.32%)	5 / 20 (25.00%)	2 / 7 (28.57%)	5 / 19 (26.32%)	6 / 17 (35.29%)	1 / 5 (20.00%)	10 / 29 (34.48%)	5 / 22 (22.73%)	4 / 22 (18.18%)	2 / 22 (9.09%)	2 / 18 (11.11%)	4 / 18 (22.22%)	17 / 44 (38.64%)
occurrences all number	3	0	5	0	1	2	0	0	5	3	3	2	0	6	6	2	6	7	1	14	7	4	3	2	4	25
Lower gastrointestinal haemorrhage
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Oesophagitis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Oral pain
subjects affected / exposed	1 / 14 (7.14%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Oral dysaesthesia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Periodontal disease
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Rectal discharge
subjects affected / exposed	1 / 14 (7.14%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Proctalgia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	3 / 44 (6.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3
Rectal haemorrhage
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	1 / 44 (2.27%)
occurrences all number	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	2	0	0	1	0	0	0	0	1	1
Stomatitis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 7 (14.29%)	2 / 19 (10.53%)	1 / 17 (5.88%)	0 / 5 (0.00%)	2 / 29 (6.90%)	2 / 22 (9.09%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	4 / 44 (9.09%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	1	2	1	0	3	2	0	0	0	0	4
Small intestinal obstruction
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Retching
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Tongue oedema
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Vomiting
subjects affected / exposed	2 / 14 (14.29%)	1 / 12 (8.33%)	3 / 15 (20.00%)	1 / 12 (8.33%)	4 / 9 (44.44%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	4 / 14 (28.57%)	2 / 5 (40.00%)	0 / 11 (0.00%)	2 / 7 (28.57%)	0 / 1 (0.00%)	1 / 19 (5.26%)	3 / 20 (15.00%)	0 / 7 (0.00%)	4 / 19 (21.05%)	4 / 17 (23.53%)	2 / 5 (40.00%)	6 / 29 (20.69%)	4 / 22 (18.18%)	2 / 22 (9.09%)	2 / 22 (9.09%)	1 / 18 (5.56%)	3 / 18 (16.67%)	10 / 44 (22.73%)
occurrences all number	4	2	3	1	5	1	0	0	4	2	0	3	0	1	4	0	4	4	2	7	5	2	5	1	3	12
Tongue ulceration
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Hepatobiliary disorders
Biliary dilatation
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Cholangitis acute
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Cholelithiasis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	1
Hyperbilirubinaemia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	2 / 19 (10.53%)	1 / 20 (5.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	2	2	0	1	0	0	0	0	0	0	1	0	1
Hepatic failure
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Hypertransaminasaemia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	3
Jaundice
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (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	0	0	0	0	0	0
Skin and subcutaneous tissue disorders
Dermatitis acneiform
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0
Dry skin
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	0 / 22 (0.00%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	2	0	1	1	0	0	1
Eczema
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	0	0
Erythema
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0	1	0	0	0
Hyperhidrosis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	2	0	1	0	0	0	1	0	1
Night sweats
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	0	1
Pain of skin
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Pruritus
subjects affected / exposed	2 / 14 (14.29%)	1 / 12 (8.33%)	4 / 15 (26.67%)	1 / 12 (8.33%)	0 / 9 (0.00%)	2 / 4 (50.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 5 (40.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	8 / 19 (42.11%)	5 / 20 (25.00%)	2 / 7 (28.57%)	4 / 19 (21.05%)	1 / 17 (5.88%)	1 / 5 (20.00%)	5 / 29 (17.24%)	4 / 22 (18.18%)	4 / 22 (18.18%)	1 / 22 (4.55%)	6 / 18 (33.33%)	3 / 18 (16.67%)	6 / 44 (13.64%)
occurrences all number	2	1	5	1	0	2	2	0	0	4	0	1	0	9	5	2	4	2	1	6	4	6	1	8	6	8
Psoriasis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Purpura
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Rash macular
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	2 / 22 (9.09%)	2 / 22 (9.09%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	1 / 44 (2.27%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	2	2	2	0	0	1	1
Rash erythematous
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0
Rash
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 5 (40.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	3 / 19 (15.79%)	0 / 20 (0.00%)	0 / 7 (0.00%)	2 / 19 (10.53%)	0 / 17 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	3 / 22 (13.64%)	3 / 22 (13.64%)	2 / 22 (9.09%)	1 / 18 (5.56%)	0 / 18 (0.00%)	6 / 44 (13.64%)
occurrences all number	0	2	0	0	0	0	0	0	0	3	0	0	0	4	0	0	2	0	0	2	3	3	2	1	0	7
Rash maculo-papular
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 12 (0.00%)	2 / 9 (22.22%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 5 (40.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	2 / 20 (10.00%)	4 / 7 (57.14%)	1 / 19 (5.26%)	1 / 17 (5.88%)	0 / 5 (0.00%)	6 / 29 (20.69%)	0 / 22 (0.00%)	3 / 22 (13.64%)	2 / 22 (9.09%)	2 / 18 (11.11%)	1 / 18 (5.56%)	4 / 44 (9.09%)
occurrences all number	0	1	1	0	2	0	0	0	0	3	1	4	0	0	2	4	1	1	0	6	0	3	2	2	1	4
Skin discolouration
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Sensitive skin
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Rash pruritic
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Skin exfoliation
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Skin hyperpigmentation
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Skin mass
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Urticaria
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0	0	1	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Skin ulcer
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Vitiligo
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	1	0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	1 / 14 (7.14%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	1	1	0	0	0	0	0	0	0	2	0	0	0	0	0	1	0	0	0	2	0	0	0	0	0	1
Bladder spasm
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Chronic kidney disease
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Chromaturia
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Dysuria
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	2 / 22 (9.09%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	2	0	0	0	0	2
Pollakiuria
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	1	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	1	1	0	0	0	0	0	0	0	1
Haematuria
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	1 / 19 (5.26%)	2 / 20 (10.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	1	0	0	1	0	1	2	0	0	0	0	0	0	0	0	0	0	0
Proteinuria
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	2 / 29 (6.90%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	1	0	2	0	0	0	0	0	0
Urinary retention
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0
Urinary incontinence
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	0
Renal failure
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 5 (40.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0
Urine odour abnormal
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Endocrine disorders
Glucocorticoid deficiency
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Hyperthyroidism
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	1 / 20 (5.00%)	1 / 7 (14.29%)	1 / 19 (5.26%)	1 / 17 (5.88%)	0 / 5 (0.00%)	3 / 29 (10.34%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	4 / 44 (9.09%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	1	1	1	1	1	0	3	1	0	0	0	1	4
Thyroiditis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	3 / 44 (6.82%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3
Inappropriate antidiuretic hormone secretion
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hypothyroidism
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	2 / 11 (18.18%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	2 / 19 (10.53%)	0 / 17 (0.00%)	0 / 5 (0.00%)	5 / 29 (17.24%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	5 / 44 (11.36%)
occurrences all number	0	0	0	0	1	0	0	0	1	0	2	1	0	0	0	1	2	0	0	5	0	0	1	0	0	5
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	1 / 14 (7.14%)	4 / 12 (33.33%)	1 / 15 (6.67%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	4 / 14 (28.57%)	1 / 5 (20.00%)	1 / 11 (9.09%)	2 / 7 (28.57%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	2 / 7 (28.57%)	4 / 19 (21.05%)	0 / 17 (0.00%)	1 / 5 (20.00%)	4 / 29 (13.79%)	2 / 22 (9.09%)	0 / 22 (0.00%)	3 / 22 (13.64%)	2 / 18 (11.11%)	2 / 18 (11.11%)	2 / 44 (4.55%)
occurrences all number	1	4	1	1	0	0	0	1	4	1	1	2	0	0	0	2	5	0	1	4	3	0	3	2	2	2
Back pain
subjects affected / exposed	4 / 14 (28.57%)	2 / 12 (16.67%)	2 / 15 (13.33%)	3 / 12 (25.00%)	2 / 9 (22.22%)	1 / 4 (25.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	2 / 11 (18.18%)	2 / 7 (28.57%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	3 / 17 (17.65%)	1 / 5 (20.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	1 / 22 (4.55%)	4 / 22 (18.18%)	2 / 18 (11.11%)	2 / 18 (11.11%)	3 / 44 (6.82%)
occurrences all number	4	2	2	3	2	1	1	0	1	0	2	3	0	1	0	1	0	3	1	1	1	1	6	2	2	3
Bone pain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Flank pain
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	1 / 5 (20.00%)	2 / 29 (6.90%)	0 / 22 (0.00%)	1 / 22 (4.55%)	2 / 22 (9.09%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	4	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	2	0	1	2	0	0	0
Joint swelling
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Groin pain
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	1	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	3	0	0
Mandibular mass
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Muscular weakness
subjects affected / exposed	0 / 14 (0.00%)	2 / 12 (16.67%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	3 / 11 (27.27%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	2 / 19 (10.53%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	1 / 22 (4.55%)	1 / 22 (4.55%)	1 / 18 (5.56%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	2	0	1	0	0	0	0	0	1	3	0	0	0	0	1	2	0	0	1	0	1	1	1	0	1
Muscle spasms
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	1 / 44 (2.27%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	1	0	0	1	0	0	0	1	0	0	0	2	1
Musculoskeletal chest pain
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	1 / 29 (3.45%)	2 / 22 (9.09%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	1	0	1	0	0	0	0	0	1	0	0	1	0	0	0	0	0	1	0	1	2	1	1	0	0	1
Musculoskeletal discomfort
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Musculoskeletal pain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0
Pain in extremity
subjects affected / exposed	2 / 14 (14.29%)	0 / 12 (0.00%)	1 / 15 (6.67%)	2 / 12 (16.67%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	2 / 5 (40.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	2 / 19 (10.53%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	0 / 22 (0.00%)	1 / 22 (4.55%)	3 / 22 (13.64%)	1 / 18 (5.56%)	1 / 18 (5.56%)	1 / 44 (2.27%)
occurrences all number	2	0	1	2	1	0	0	0	0	2	1	0	0	2	1	0	0	0	0	2	0	1	3	1	1	1
Neck pain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	1	0	0
Myalgia
subjects affected / exposed	2 / 14 (14.29%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	2 / 22 (9.09%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	3 / 44 (6.82%)
occurrences all number	2	0	0	0	0	0	0	0	1	0	0	1	0	0	0	1	0	0	0	1	1	2	1	0	0	3
Pain in jaw
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Pathological fracture
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Sacral pain
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Soft tissue necrosis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Spinal stenosis
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Infections and infestations
Abdominal abscess
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Abscess limb
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Acarodermatitis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Biliary tract infection
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
COVID-19
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	1 / 1 (100.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	1 / 22 (4.55%)	0 / 22 (0.00%)	1 / 22 (4.55%)	1 / 18 (5.56%)	0 / 18 (0.00%)	5 / 44 (11.36%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	2	1	0	1	0	1	0	0	2	1	0	1	1	0	5
Candida infection
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0	0	0	0
Clostridium difficile colitis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	2 / 11 (18.18%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Clostridium difficile infection
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Conjunctivitis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	2 / 22 (9.09%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	2	0	0	0	0	0
Cystitis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	1	0	0	0
Device related infection
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0
Ear infection
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Enterocolitis infectious
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0
Escherichia urinary tract infection
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Folliculitis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Fungal skin infection
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Gastroenteritis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0
Gingivitis
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0
Herpes zoster
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	2 / 29 (6.90%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	2	0	0	0	0	0	1
Influenza
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0
Mucosal infection
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Oral herpes
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	1	0	1
Oral fungal infection
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0	0
Oral candidiasis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0
Nasopharyngitis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	1 / 29 (3.45%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	1	0	1	0	0	0	0	0	0
Pharyngitis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Pneumonia
subjects affected / exposed	1 / 14 (7.14%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	3 / 11 (27.27%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	1 / 22 (4.55%)	2 / 22 (9.09%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	1	1	0	0	0	1	0	0	0	0	3	0	0	0	1	0	0	0	0	1	4	1	2	0	0	2
Pseudomonas infection
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0
Respiratory tract infection
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	1 / 5 (20.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	1	2	0	0	0	0	0
Rhinitis
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 18 (0.00%)	1 / 18 (5.56%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	1	1
Skin infection
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	1 / 12 (8.33%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	1	0	1	1	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	1	0	0	1	0
Staphylococcal bacteraemia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Upper respiratory tract infection
subjects affected / exposed	1 / 14 (7.14%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	2 / 29 (6.90%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	2	0	0	0	0	0	2
Tinea cruris
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Urinary tract infection
subjects affected / exposed	0 / 14 (0.00%)	2 / 12 (16.67%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	2 / 20 (10.00%)	2 / 7 (28.57%)	0 / 19 (0.00%)	2 / 17 (11.76%)	0 / 5 (0.00%)	0 / 29 (0.00%)	2 / 22 (9.09%)	1 / 22 (4.55%)	2 / 22 (9.09%)	1 / 18 (5.56%)	2 / 18 (11.11%)	4 / 44 (9.09%)
occurrences all number	0	4	0	2	0	0	1	0	0	0	0	0	0	1	2	2	0	3	0	0	3	1	3	2	2	5
Vaginal infection
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	1 / 14 (7.14%)	2 / 12 (16.67%)	4 / 15 (26.67%)	0 / 12 (0.00%)	2 / 9 (22.22%)	2 / 4 (50.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	2 / 14 (14.29%)	2 / 5 (40.00%)	7 / 11 (63.64%)	1 / 7 (14.29%)	0 / 1 (0.00%)	4 / 19 (21.05%)	3 / 20 (15.00%)	2 / 7 (28.57%)	11 / 19 (57.89%)	6 / 17 (35.29%)	0 / 5 (0.00%)	8 / 29 (27.59%)	8 / 22 (36.36%)	10 / 22 (45.45%)	5 / 22 (22.73%)	2 / 18 (11.11%)	3 / 18 (16.67%)	16 / 44 (36.36%)
occurrences all number	1	2	4	0	2	2	0	1	2	2	7	1	0	4	3	2	12	7	0	9	10	10	5	2	3	21
Folate deficiency
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Dehydration
subjects affected / exposed	1 / 14 (7.14%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	1 / 5 (20.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	4 / 19 (21.05%)	0 / 17 (0.00%)	0 / 5 (0.00%)	3 / 29 (10.34%)	0 / 22 (0.00%)	2 / 22 (9.09%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	1	0	0	0	0	0	0	0	1	1	1	1	0	1	0	0	4	0	0	5	0	2	0	0	0	3
Hyperchloraemia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hypercalcaemia
subjects affected / exposed	1 / 14 (7.14%)	1 / 12 (8.33%)	2 / 15 (13.33%)	2 / 12 (16.67%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	1 / 29 (3.45%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	1	1	2	2	0	0	0	0	1	0	0	1	0	0	0	0	1	0	0	1	1	1	0	0	2	0
Hyperglycaemia
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	1 / 12 (8.33%)	1 / 9 (11.11%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	1 / 14 (7.14%)	0 / 5 (0.00%)	2 / 11 (18.18%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	2 / 20 (10.00%)	0 / 7 (0.00%)	2 / 19 (10.53%)	1 / 17 (5.88%)	0 / 5 (0.00%)	3 / 29 (10.34%)	4 / 22 (18.18%)	2 / 22 (9.09%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	0	1	0	1	1	0	1	0	1	0	4	0	0	0	2	0	4	1	0	4	5	2	0	1	0	2
Hyperkalaemia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	2 / 15 (13.33%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	2 / 20 (10.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	1 / 44 (2.27%)
occurrences all number	0	0	2	0	1	0	0	0	0	0	0	0	0	0	2	0	0	1	0	0	0	0	0	0	1	1
Hypernatraemia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hypermagnesaemia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	1 / 12 (8.33%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	1 / 17 (5.88%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	1	0	0
Hyperphosphataemia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Hyperuricaemia
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	2	0	1	1	0	0	1	0	0	0	0	0	0	3	0	0	0	0
Hypoalbuminaemia
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	1 / 15 (6.67%)	0 / 12 (0.00%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	3 / 5 (60.00%)	3 / 11 (27.27%)	0 / 7 (0.00%)	0 / 1 (0.00%)	3 / 19 (15.79%)	1 / 20 (5.00%)	3 / 7 (42.86%)	2 / 19 (10.53%)	1 / 17 (5.88%)	1 / 5 (20.00%)	1 / 29 (3.45%)	2 / 22 (9.09%)	0 / 22 (0.00%)	1 / 22 (4.55%)	1 / 18 (5.56%)	0 / 18 (0.00%)	3 / 44 (6.82%)
occurrences all number	0	1	1	0	1	0	0	0	2	3	3	0	0	3	1	3	2	1	1	1	2	0	1	1	0	3
Hypocalcaemia
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	1 / 9 (11.11%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	2 / 14 (14.29%)	2 / 5 (40.00%)	0 / 11 (0.00%)	2 / 7 (28.57%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 7 (14.29%)	0 / 19 (0.00%)	2 / 17 (11.76%)	0 / 5 (0.00%)	2 / 29 (6.90%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	1	0	0	1	1	0	0	3	2	0	2	0	0	1	1	0	2	0	2	2	1	0	0	0	2
Hypokalaemia
subjects affected / exposed	1 / 14 (7.14%)	3 / 12 (25.00%)	1 / 15 (6.67%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	3 / 14 (21.43%)	4 / 5 (80.00%)	3 / 11 (27.27%)	1 / 7 (14.29%)	0 / 1 (0.00%)	4 / 19 (21.05%)	1 / 20 (5.00%)	1 / 7 (14.29%)	4 / 19 (21.05%)	2 / 17 (11.76%)	0 / 5 (0.00%)	4 / 29 (13.79%)	2 / 22 (9.09%)	0 / 22 (0.00%)	2 / 22 (9.09%)	3 / 18 (16.67%)	2 / 18 (11.11%)	1 / 44 (2.27%)
occurrences all number	2	5	1	0	0	0	0	1	4	5	6	1	0	4	1	1	8	3	0	4	2	0	3	3	3	1
Hypoglycaemia
subjects affected / exposed	0 / 14 (0.00%)	1 / 12 (8.33%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	1 / 7 (14.29%)	1 / 19 (5.26%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	1	1	0	0	0	1	2	0	0	0	1	0	0	0	0	0
Hypomagnesaemia
subjects affected / exposed	1 / 14 (7.14%)	1 / 12 (8.33%)	2 / 15 (13.33%)	0 / 12 (0.00%)	3 / 9 (33.33%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	1 / 5 (20.00%)	3 / 11 (27.27%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	1 / 20 (5.00%)	1 / 7 (14.29%)	4 / 19 (21.05%)	0 / 17 (0.00%)	0 / 5 (0.00%)	3 / 29 (10.34%)	2 / 22 (9.09%)	0 / 22 (0.00%)	1 / 22 (4.55%)	1 / 18 (5.56%)	1 / 18 (5.56%)	2 / 44 (4.55%)
occurrences all number	2	2	2	0	3	0	0	0	0	1	4	1	0	0	1	3	6	0	0	3	2	0	1	1	1	2
Hyponatraemia
subjects affected / exposed	3 / 14 (21.43%)	4 / 12 (33.33%)	1 / 15 (6.67%)	2 / 12 (16.67%)	1 / 9 (11.11%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	4 / 14 (28.57%)	4 / 5 (80.00%)	4 / 11 (36.36%)	1 / 7 (14.29%)	0 / 1 (0.00%)	3 / 19 (15.79%)	3 / 20 (15.00%)	3 / 7 (42.86%)	3 / 19 (15.79%)	4 / 17 (23.53%)	1 / 5 (20.00%)	4 / 29 (13.79%)	4 / 22 (18.18%)	0 / 22 (0.00%)	1 / 22 (4.55%)	1 / 18 (5.56%)	2 / 18 (11.11%)	7 / 44 (15.91%)
occurrences all number	4	7	1	3	2	2	0	0	6	6	5	4	0	4	3	5	5	4	1	5	4	0	1	4	2	8
Hypophosphataemia
subjects affected / exposed	1 / 14 (7.14%)	2 / 12 (16.67%)	1 / 15 (6.67%)	1 / 12 (8.33%)	1 / 9 (11.11%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	2 / 14 (14.29%)	0 / 5 (0.00%)	1 / 11 (9.09%)	2 / 7 (28.57%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	3 / 7 (42.86%)	1 / 19 (5.26%)	1 / 17 (5.88%)	0 / 5 (0.00%)	2 / 29 (6.90%)	1 / 22 (4.55%)	1 / 22 (4.55%)	0 / 22 (0.00%)	1 / 18 (5.56%)	0 / 18 (0.00%)	2 / 44 (4.55%)
occurrences all number	1	3	1	1	2	0	0	1	2	0	1	2	0	0	0	3	2	1	0	3	1	1	0	1	0	2
Iron deficiency
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	1 / 11 (9.09%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0
Malnutrition
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	1 / 7 (14.29%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	1 / 44 (2.27%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0	0	1
Steroid diabetes
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	1 / 19 (5.26%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 22 (0.00%)	0 / 18 (0.00%)	0 / 18 (0.00%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	0	0	0	0	0	0	0	0	0	0
Type 2 diabetes mellitus
subjects affected / exposed	0 / 14 (0.00%)	0 / 12 (0.00%)	0 / 15 (0.00%)	0 / 12 (0.00%)	0 / 9 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 14 (0.00%)	0 / 5 (0.00%)	0 / 11 (0.00%)	0 / 7 (0.00%)	0 / 1 (0.00%)	0 / 19 (0.00%)	0 / 20 (0.00%)	0 / 7 (0.00%)	0 / 19 (0.00%)	0 / 17 (0.00%)	0 / 5 (0.00%)	0 / 29 (0.00%)	0 / 22 (0.00%)	1 / 22 (4.55%)	0 / 22 (0.00%)	0 / 18 (0.00%)	1 / 18 (5.56%)	0 / 44 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	0	1	0	0	1	0

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

05 Apr 2017

Incorporates revisions to the inclusion/exclusion criteria, study schematic, timing of pharmacokinetic and pharmacodynamic collection, and rectified inconsistencies in cohort sample size and administrative updates.

14 Feb 2018

Expand enrollment in Part 1A to include up to 60 participants, extend the treatment period to 2 calendar years, modify eligibility criteria for participants with advanced PDAC, permit the use of concomitant palliative hormonal therapy, remove the option of re-treatmentfollowing progression, and modify the biomarker sampling schedule

24 Oct 2018

Updated the study design as follows: Part 1A: Inclusion of alternative every-2-weeks (Q2W) dosing schedule to study BMS-986218 in the context of rapid T-regulatory cell (Treg) depletion and recovery. Part 1B: Inclusion of Bayesian Logistic Regression Model (BLRM) using the escalation with overdose control (EWOC) principle, and a starting dose 1 at dose level below the current safety cleared monotherapy cohort (to allow initiation of this study part prior to declaring the RP2D and evaluation of different doses in combination in select tumor types) Part2A: Inclusion of several dose levels and/or schedules to study BMS-986218 monotherapy and ipilimumab monotherapy in a randomized setting in participants with cutaneous melanoma Part 2B: Inclusion of several dose levels and/or schedules to study BMS-986218 monotherapy in a randomized setting in participants with non-small cell lung cancer (NSCLC). Other key changes: updated to on-treatment biopsy timing from C1D22 to C2D8; clarified expectations and timing of scheduled activities; updated eligibility criteria; and added tumor marker and patient-reported outcomes assessments to the study.

25 Dec 2018

The primary reasons for the changes to the protocol are to: 1)Update pharmacokinetic and immunogenicity assessments sampling schedules to add and/or clarify blood and anti-drug antibody samples. 2)Clarify relevant systemic exposure of study drugs for male participant contraceptive guidance.

14 Aug 2019

The primary reasons for the changes to the protocolare: 1)Specify interim dose levels for Part 1A and Part 1B. 2)Include a subgroup of additional participants with advanced stage cutaneous melanoma in Part 1A. 3)Specify the doses and schedules for expansions in Part 2A and Part 2B. 4)Update safety information to align with current Investigator Brochure for BMS-986218.

22 Dec 2020

The changes include revising the protocol in response to feedback from Investigators and Health Authorities around pregnancy testing and contraception requirements, adding responses to the COVID-19 pandemic and aligning with nivolumab program standards, including updating the contraception language for women of child-bearing potential (WOCBP) participants and male participants, and their WOCBP partners.

29 Jul 2021

Added Part 2C and Part 2D evaluating the combination of anti-CTLA4-NF (BMS-986218) and nivolumab in non-small cell lung cancer (NSCLC) and microsatellite stable colorectal cancer (MSS CRC) participants, respectively. Incorporates Protocol Amendment 01 United States.

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials

Clinical Trial Results: Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody 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)

Primary: Number of Participants with Adverse Events (AEs)

Primary: Number of Participants with Serious Adverse Events (SAEs)

Primary: Number of Participants with Serious Adverse Events (SAEs)

Primary: Number of Participants with Adverse Events (AEs) meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria

Primary: Number of Participants with Adverse Events (AEs) meeting Protocol-defined Dose-limiting Toxicity (DLT) Criteria

Primary: Number of Participants with Adverse Events (AEs) Leading to Discontinuation

Primary: Number of Participants with Adverse Events (AEs) Leading to Discontinuation

Primary: Number of Participants Who Died

Primary: Number of Participants Who Died

Primary: Objective Response Rate (ORR) for Part 2 only

Primary: Objective Response Rate (ORR) for Part 2 only

Primary: Median Duration of Response (mDOR) for Part 2 only

Primary: Median Duration of Response (mDOR) for Part 2 only

Primary: Progression-free Survival Rate (PFSR) at 24, 36, and 48 weeks for Part 2 only

Primary: Progression-free Survival Rate (PFSR) at 24, 36, and 48 weeks for Part 2 only

Secondary: Objective Response Rate (ORR) for Part1A and Part1B only

Secondary: Objective Response Rate (ORR) for Part1A and Part1B only

Secondary: Median Duration of Response (mDOR) for Part1A and Part1B only

Secondary: Median Duration of Response (mDOR) for Part1A and Part1B only

Secondary: Progression-free Survival Rate (PFSR) at 24, 36, and 48 weeks for Part1A and Part1B only

Secondary: Progression-free Survival Rate (PFSR) at 24, 36, and 48 weeks for Part1A and Part1B only

Secondary: Maximum Observed Serum Concentration (Cmax) for BMS-986218

Secondary: Maximum Observed Serum Concentration (Cmax) for BMS-986218

Secondary: Area under the Concentration-time Curve from Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218

Secondary: Area under the Concentration-time Curve from Time Zero to the Time of the Last Quantifiable Concentration [AUC(0-T)] for BMS-986218

Secondary: Area under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218

Secondary: Area under the Concentration-time Curve in 1 Dosing Interval [AUC(TAU)] for BMS-986218

Secondary: Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218

Secondary: Observed Concentration at the End of a Dosing Interval (Ctau) for BMS-986218

Secondary: Total Body Clearance (CLT/F) for BMS-986218

Secondary: Total Body Clearance (CLT/F) for BMS-986218

Secondary: Average Concentration over a Dosing Interval (AUC[TAU]/tau) at Steady State (Css-avg) for BMS-986218

Secondary: Average Concentration over a Dosing Interval (AUC[TAU]/tau) at Steady State (Css-avg) for BMS-986218

Secondary: Ratio of an Exposure Measure at Steady State to that After the First Dose (Exposure Measure includes Cmax) (AI_Cmax) for BMS-986218

Secondary: Ratio of an Exposure Measure at Steady State to that After the First Dose (Exposure Measure includes Cmax) (AI_Cmax) for BMS-986218

Secondary: Accumulation Index Ratio of AUC at Steady State to that After the First Dose (AI_AUC) for BMS-986218

Secondary: Accumulation Index Ratio of AUC at Steady State to that After the First Dose (AI_AUC) for BMS-986218

Secondary: Terminal Serum Half-life (T-HALF) for BMS-986218

Secondary: Terminal Serum Half-life (T-HALF) for BMS-986218

Secondary: Time of Maximum Observed Concentration (Tmax) for BMS-986218

Secondary: Time of Maximum Observed Concentration (Tmax) for BMS-986218

Secondary: Trough Observed Plasma Concentration (Ctrough) for BMS-986218

Secondary: Trough Observed Plasma Concentration (Ctrough) for BMS-986218

Secondary: Number of Participants with Anti-drug Antibodies (ADA) to BMS-986218

Secondary: Number of Participants with Anti-drug Antibodies (ADA) to BMS-986218

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
Phase 1/2a First-In-Human Study of BMS-986218 Monoclonal Antibody Alone and in Combination with Nivolumab in Advanced Solid Tumors