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Clinical Trial Results:
A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, as Monotherapy or in Combination with Nivolumab in Subjects with Selected Advanced Solid Tumors or Hematologic Malignancies

Summary
EudraCT number	2015-000324-29
Trial protocol	ES NL BE GB FR
Global end of trial date	17 Mar 2021

Results information
Results version number	v1(current)
This version publication date	29 Mar 2022
First version publication date	29 Mar 2022
Other versions

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

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Trial information

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Sponsor protocol code

CA011-001

ISRCTN number

US NCT number

WHO universal trial number (UTN)

Sponsor organisation name

Bristol-Myers Squibb

Sponsor organisation address

Chaussée de la Hulpe 185, Brussels, Belgium, 1170

Public contact

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

25 Aug 2021

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

17 Mar 2021

Was the trial ended prematurely?

Main objective of the trial

To assess the safety and tolerability and to assess the DLTs, MTD, and recommended Phase 2 dose (RP2D) of BMS-986158 as monotherapy for subjects with advanced solid tumors and hematologic malignancies.

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

19 Jun 2015

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Australia: 12

Country: Number of subjects enrolled

Canada: 32

Country: Number of subjects enrolled

France: 13

Country: Number of subjects enrolled

United States: 26

Worldwide total number of subjects

EEA total number of subjects

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)

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

Screening details

83 participants were treated.

Period 1 title

Overall Study (overall period)

Is this the baseline period?

Yes

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

Are arms mutually exclusive

Yes

Part 1 Schedule A - BMS-986158 0.75 mg

Arm description

Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986158-01

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

0.75 mg - single dose at first - approximately 7 days later, same dose QD for 5 days followed by a 2 days rest period

Part 1 Schedule A - BMS-986158 1.25 mg

Arm description

Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986158-01

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

1.25 mg - single dose at first - approximately 7 days later, same dose QD for 5 days followed by a 2 days rest period

Part 1 Schedule A - BMS-986158 2 mg

Arm description

Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986158-01

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

2 mg - single dose at first - approximately 7 days later, same dose QD for 5 days followed by a 2 days rest period

Part 1 Schedule A - BMS-986158 3 mg

Arm description

Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986158-01

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

3 mg - single dose at first - approximately 7 days later, same dose QD for 5 days followed by a 2 days rest period

Part 1 Schedule A - BMS-986158 4.5 mg

Arm description

Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986158-01

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

4.5 mg - single dose at first - approximately 7 days later, same dose QD for 5 days followed by a 2 days rest period

Part 1 Schedule B - BMS-986158 2 mg

Arm description

Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986158-01

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

2 mg - single dose at first - approximately 7 days later, same dose QD for 14 days followed by a 7 days rest period

Part 1 Schedule B - BMS-986158 3 mg

Arm description

Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986158-01

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

3 mg - single dose at first - approximately 7 days later, same dose QD for 14 days followed by a 7 days rest period

Part 1 Schedule C - BMS-986158 2 mg

Arm description

Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986158-01

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

2 mg - single dose at first - approximately 7 days later, same dose QD for 7 days followed by a 14 days rest period

Part 1 Schedule C - BMS-986158 3 mg

Arm description

Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986158-01

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

3 mg - single dose at first - approximately 7 days later, same dose QD for 7 days followed by a 14 days rest period

Part 1 Schedule C - BMS-986158 4.5 mg

Arm description

Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986158-01

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

4.5 mg - single dose at first - approximately 7 days later, same dose QD for 7 days followed by a 14 days rest period

Part 2 Schedule A

Arm description

BMS-986158 administered at 4.5 mg QD for 5 consecutive days, followed by a 2 days resting period, for a total of 10 doses. Then, BMS-986158 is administered at the 3.75 mg dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986158-01

Investigational medicinal product code

Other name

Pharmaceutical forms

Capsule

Routes of administration

Oral use

Dosage and administration details

4.5 mg QD 5days on 2 days off for 10 cycles. Later, 3 mg QD 5days on 2 days off

Number of subjects in period 1	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg	Part 2 Schedule A
Started	5	4	13	10	13	4	4	6	13	10	1
Completed	0	0	0	0	0	0	0	0	0	0	0
Not completed	5	4	13	10	13	4	4	6	13	10	1
Consent withdrawn by subject	-	-	-	-	-	-	-	-	-	-	1
Disease progression	5	4	13	10	10	3	4	5	13	9	-
Study drug toxicity	-	-	-	-	1	-	-	-	-	-	-
Participant request to discontinue	-	-	-	-	-	-	-	-	-	1	-
Adverse event unrelated to study drug	-	-	-	-	2	1	-	1	-	-	-

Baseline characteristics

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Reporting group title

Part 1 Schedule A - BMS-986158 0.75 mg

Reporting group description

Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Reporting group title

Part 1 Schedule A - BMS-986158 1.25 mg

Reporting group description

Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Reporting group title

Part 1 Schedule A - BMS-986158 2 mg

Reporting group description

Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Reporting group title

Part 1 Schedule A - BMS-986158 3 mg

Reporting group description

Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Reporting group title

Part 1 Schedule A - BMS-986158 4.5 mg

Reporting group description

Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Reporting group title

Part 1 Schedule B - BMS-986158 2 mg

Reporting group description

Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle

Reporting group title

Part 1 Schedule B - BMS-986158 3 mg

Reporting group description

Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle

Reporting group title

Part 1 Schedule C - BMS-986158 2 mg

Reporting group description

Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle

Reporting group title

Part 1 Schedule C - BMS-986158 3 mg

Reporting group description

Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle

Reporting group title

Part 1 Schedule C - BMS-986158 4.5 mg

Reporting group description

Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle

Reporting group title

Part 2 Schedule A

Reporting group description

Reporting group values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg	Part 2 Schedule A	Total
Number of subjects	5	4	13	10	13	4	4	6	13	10	1	83
Age Categorical
Units: Participants
<=18 years	0	0	0	0	0	0	0	0	0	0	0	0
Between 18 and 65 years	4	4	7	7	10	3	2	6	12	7	1	63
>=65 years	1	0	6	3	3	1	2	0	1	3	0	20
Age Continuous
Units: Years
arithmetic mean (standard deviation)	61.4 ( 7.2 )	45.0 ( 9.4 )	63.2 ( 12.1 )	54.3 ( 16.4 )	55.5 ( 15.4 )	61.3 ( 3.0 )	68.5 ( 5.4 )	58.8 ( 2.7 )	53.6 ( 9.1 )	58.1 ( 9.9 )	30.0 ( 99999 )	-
Sex: Female, Male
Units: Participants
Female	5	3	12	7	9	2	3	5	9	9	0	64
Male	0	1	1	3	4	2	1	1	4	1	1	19
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0	0
Asian	0	0	1	0	0	0	0	0	1	1	1	4
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0	0
Black or African American	0	1	0	0	1	0	0	0	0	0	0	2
White	5	3	11	10	10	4	4	6	8	8	0	69
More than one race	0	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	1	0	2	0	0	0	4	1	0	8
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	0	0	0	0	0	0	0	1	1	1	0	3
Not Hispanic or Latino	0	1	6	6	5	2	2	4	4	6	1	37
Unknown or Not Reported	5	3	7	4	8	2	2	1	8	3	0	43

Subject analysis set title

Schedule A

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at any dose under Schedule A regimen (5 days on treatment, 2 days off treatment).

Subject analysis set title

Schedule B

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at any dose under Schedule B regimen (14 days on treatment, 7 days off treatment).

Subject analysis set title

Schedule C

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at any dose under Schedule C regimen (7 days on treatment, 14 days off treatment).

Subject analysis set title

BMS-986158 0.75 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 0.75 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 1.25 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 1.25 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 2 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 2 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 3 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 3 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 4.5 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 4.5 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 0.75 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 0.75 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 2 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 2 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 3 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 3 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 4.5 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 4.5 mg dose, regardless of the dosing schedule.

Subject analysis sets values	Schedule A	Schedule B	Schedule C	BMS-986158 0.75 mg	BMS-986158 1.25 mg	BMS-986158 2 mg	BMS-986158 3 mg	BMS-986158 4.5 mg	BMS-986158 0.75 mg	BMS-986158 2 mg	BMS-986158 3 mg	BMS-986158 4.5 mg
Number of subjects	46	8	29	5	3	16	25	17	4	11	18	14
Age Categorical
Units: Participants
<=18 years	0	0	0
Between 18 and 65 years	33	5	25
>=65 years	13	3	4
Age Continuous
Units: Years
arithmetic mean (standard deviation)	56.6 ( 14.5 )	64.9 ( 5.6 )	56.2 ( 8.6 )	( )	( )	( )	( )	( )	( )	( )	( )	( )
Sex: Female, Male
Units: Participants
Female	36	5	23
Male	10	3	6
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0
Asian	2	0	2
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	2	0	0
White	39	8	22
More than one race	0	0	0
Unknown or Not Reported	3	0	5
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	0	0	3
Not Hispanic or Latino	19	4	14
Unknown or Not Reported	27	4	12

End points

Top of page

Reporting group title

Part 1 Schedule A - BMS-986158 0.75 mg

Reporting group description

Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Reporting group title

Part 1 Schedule A - BMS-986158 1.25 mg

Reporting group description

Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Reporting group title

Part 1 Schedule A - BMS-986158 2 mg

Reporting group description

Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Reporting group title

Part 1 Schedule A - BMS-986158 3 mg

Reporting group description

Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Reporting group title

Part 1 Schedule A - BMS-986158 4.5 mg

Reporting group description

Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Reporting group title

Part 1 Schedule B - BMS-986158 2 mg

Reporting group description

Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle

Reporting group title

Part 1 Schedule B - BMS-986158 3 mg

Reporting group description

Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle

Reporting group title

Part 1 Schedule C - BMS-986158 2 mg

Reporting group description

Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle

Reporting group title

Part 1 Schedule C - BMS-986158 3 mg

Reporting group description

Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle

Reporting group title

Part 1 Schedule C - BMS-986158 4.5 mg

Reporting group description

Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle

Reporting group title

Part 2 Schedule A

Reporting group description

Subject analysis set title

Schedule A

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at any dose under Schedule A regimen (5 days on treatment, 2 days off treatment).

Subject analysis set title

Schedule B

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at any dose under Schedule B regimen (14 days on treatment, 7 days off treatment).

Subject analysis set title

Schedule C

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at any dose under Schedule C regimen (7 days on treatment, 14 days off treatment).

Subject analysis set title

BMS-986158 0.75 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 0.75 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 1.25 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 1.25 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 2 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 2 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 3 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 3 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 4.5 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 4.5 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 0.75 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 0.75 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 2 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 2 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 3 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 3 mg dose, regardless of the dosing schedule.

Subject analysis set title

BMS-986158 4.5 mg

Subject analysis set type

Sub-group analysis

Subject analysis set description

All participants treated with BMS-986158 at 4.5 mg dose, regardless of the dosing schedule.

Primary: Number of Participants Experiencing Adverse Events

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End point title

Number of Participants Experiencing Adverse Events ^[1]

End point description

Number of participants experiencing different types of events, including Adverse Events (AEs), Serious Adverse Events (SAEs), AEs leading to discontinuation and deaths. Events are classified based on the NCI Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.

End point type

Primary

End point timeframe

From first dose to 30 days following last dose (up to approximately 29 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: No statistical analyses were performed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg	Part 2 Schedule A
Number of subjects analysed	5	4	13	10	13	4	4	6	13	10	1
Units: Participants
Adverse Events (AEs)	5	4	13	10	13	4	4	6	13	9	1
Serious Adverse Events (SAEs)	3	3	7	7	9	2	2	4	5	3	0
AEs leading to discontinuation	0	0	0	1	3	1	0	1	0	0	0
Deaths	0	1	2	4	3	0	0	1	2	0	0

No statistical analyses for this end point

Primary: Number of Participants With Abnormal Hepatic Test Values

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End point title

Number of Participants With Abnormal Hepatic Test Values ^[2]

End point description

Number of participants experiencing abnormal hepatic function, as measured by different parameters. ALT = Alanine aminotransferase AST = Aspartate aminotransferase ULN = Upper Limit of Normal

End point type

Primary

End point timeframe

From first dose to 30 days following last dose (up to approximately 29 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: No statistical analyses were performed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg	Part 2 Schedule A
Number of subjects analysed	5	4	13	10	13	4	4	6	13	10	1
Units: Participants
ALT OR AST > 3XULN	2	1	2	2	2	0	1	0	2	2	0
ALT OR AST > 5XULN	1	0	2	1	2	0	0	0	2	1	0
ALT OR AST > 10XULN	0	0	1	1	0	0	0	0	0	0	0
ALT OR AST > 20XULN	0	0	0	0	0	0	0	0	0	0	0
TOTAL BILIRUBIN > 2XULN	1	0	0	1	4	0	1	0	0	1	1
ALT OR AST > 3XULN + BILIRUB > 2XULN W/ 1 DAY	1	0	0	1	0	0	0	0	0	1	0
ALT OR AST > 3XULN + BILIRUB > 2XULN W/ 30 DAYS	1	0	0	1	0	0	1	0	0	1	0

No statistical analyses for this end point

Secondary: Best Overall Response (BOR)

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End point title

Best Overall Response (BOR)

End point description

BOR, as assessed by the investigator, is defined as the best response designation, recorded between the dates of first dose and the date of first objectively documented progression (per RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies or PCWG3 for prostate cancer) or the date of subsequent therapy, whichever occurs first.

End point type

Secondary

End point timeframe

From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg	Part 2 Schedule A
Number of subjects analysed	5	4	13	10	13	4	4	6	13	10	1
Units: Participants
Complete Response	0	0	0	0	0	0	0	0	0	0	0
Partial Response	0	0	0	0	1	0	0	0	0	0	1
Stable Disease	1	1	2	1	7	2	1	1	4	4	0
Progressive Disease	4	2	8	7	3	2	2	2	9	4	0
Unable to determine	0	1	3	2	2	0	1	3	0	2	0

No statistical analyses for this end point

Secondary: Objective Response Rate (ORR)

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End point title

Objective Response Rate (ORR)

End point description

ORR is defined as the percentage of participants who achieved a best overall response of Complete Response (CR) or Partial Response (PR)

End point type

Secondary

End point timeframe

From first dose to date of first documented progression or subsequent therapy (up to approximately 28 months)

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg	Part 2 Schedule A
Number of subjects analysed	5	4	13	10	13	4	4	6	13	10	1
Units: Percent of Participants
number (confidence interval 95%)	0 (0.0 to 52.2)	0 (0.0 to 60.2)	0 (0.0 to 24.7)	0 (0.0 to 30.8)	7.7 (0.2 to 36.0)	0 (0.0 to 60.2)	0 (0.0 to 60.2)	0 (0.0 to 45.9)	0 (0.0 to 24.7)	0 (0.0 to 30.8)	100.0 (2.5 to 100.0)

No statistical analyses for this end point

Secondary: Duration of Response (DOR)

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End point title

Duration of Response (DOR)

End point description

DOR is defined as the time between the date of first response and the date of the first objectively documented disease progression (as determined by RECIST v1.1 for solid tumors, Lugano 2014 criteria for hematologic malignancies, or PCWG3 (including PSA assessments) for prostate cancer [CRPC or NEPC]), or death due to any cause, whichever occurs first.

End point type

Secondary

End point timeframe

From date of first response to date of first objectively documented disease progression or death (up to approximately 42 weeks)

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg	Part 2 Schedule A
Number of subjects analysed	0 ^[3]	0 ^[4]	0 ^[5]	0 ^[6]	1	0 ^[7]	0 ^[8]	0 ^[9]	0 ^[10]	0 ^[11]	1
Units: Weeks
arithmetic mean (standard deviation)	( )	( )	( )	( )	22.3 ( 99999 )	( )	( )	( )	( )	( )	42.4 ( 99999 )

Notes
[3] - No responders in this cohort
[4] - No responders in this cohort
[5] - No responders in this cohort
[6] - No responders in this cohort
[7] - No responders in this cohort
[8] - No responders in this cohort
[9] - No responders in this cohort
[10] - No responders in this cohort
[11] - No responders in this cohort

No statistical analyses for this end point

Secondary: Progression Free Survival (PFS)

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End point title

Progression Free Survival (PFS)

End point description

PFS is defined as the time from the first dose of study medication to the date of the first objective documentation of tumor progression or death due to any cause.

End point type

Secondary

End point timeframe

From first dose to date of first objectively documented disease progression or death (up to approximately 28 months)

End point values	Schedule A	Schedule B	Schedule C
Number of subjects analysed	46	8	29
Units: Weeks
median (confidence interval 95%)	8.29 (7.14 to 9.71)	8.43 (5.57 to 40.14)	9.00 (7.86 to 13.29)

No statistical analyses for this end point

Secondary: Progression Free Survival Rate (PFSR)

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End point title

Progression Free Survival Rate (PFSR)

End point description

PFSR is defined as the percentage of participants who remain progression free and surviving at the specified timepoints (12 weeks, 24 weeks, and 48 weeks). Reported values are estimates derived from Kaplan-Meier analyses

End point type

Secondary

End point timeframe

From first dose to 12 weeks, to 24 weeks, and to 48 weeks after first dose

End point values	Schedule A	Schedule B	Schedule C
Number of subjects analysed	46	8	29
Units: Percent of participants
number (confidence interval 95%)
12 weeks	31.0 (17.4 to 45.6)	42.9 (9.8 to 73.4)	31.6 (14.2 to 50.6)
24 weeks	18.1 (8.0 to 31.5)	42.9 (9.8 to 73.4)	13.5 (3.4 to 30.6)
48 weeks	10.3 (3.3 to 22.1)	14.3 (0.7 to 46.5)	6.8 (0.6 to 24.4)

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration

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End point title

Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration

End point description

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

End point type

Secondary

End point timeframe

From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

End point values	BMS-986158 0.75 mg	BMS-986158 1.25 mg	BMS-986158 2 mg	BMS-986158 3 mg	BMS-986158 4.5 mg
Number of subjects analysed	5	3	16	25	17
Units: ng/mL
geometric mean (geometric coefficient of variation)
Parent BMS-986158	68.8 ( 23 )	175 ( 36 )	269 ( 25 )	368 ( 30 )	513 ( 25 )
Metabolite BMT-161485	5.00 ( 30 )	10.0 ( 29 )	18.2 ( 36 )	21.6 ( 47 )	35.6 ( 41 )

No statistical analyses for this end point

Secondary: Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration

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End point title

Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration

End point description

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

End point type

Secondary

End point timeframe

From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

End point values	BMS-986158 0.75 mg	BMS-986158 1.25 mg	BMS-986158 2 mg	BMS-986158 3 mg	BMS-986158 4.5 mg
Number of subjects analysed	5	3	16	25	17
Units: Hours
median (full range (min-max))
Parent BMS-986158	4.00 (2.00 to 4.02)	1.00 (1.00 to 2.00)	1.04 (0.500 to 4.03)	1.02 (0.500 to 6.15)	2.02 (1.00 to 4.03)
Metabolite BMT-161485	24.0 (2.55 to 24.2)	2.00 (2.00 to 24.0)	6.00 (1.00 to 72.0)	3.03 (0.983 to 48.0)	6.27 (1.00 to 48.0)

No statistical analyses for this end point

Secondary: Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration

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End point title

Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration

End point description

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

End point type

Secondary

End point timeframe

From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

End point values	BMS-986158 0.75 mg	BMS-986158 1.25 mg	BMS-986158 2 mg	BMS-986158 3 mg	BMS-986158 4.5 mg
Number of subjects analysed	5	3	16	25	17
Units: hr*ng/mL
geometric mean (geometric coefficient of variation)
Parent BMS-986158	1027 ( 16 )	2309 ( 13 )	3533 ( 25 )	4989 ( 38 )	7039 ( 34 )
Metabolite BMT-161485	98.2 ( 34 )	188 ( 11 )	310 ( 35 )	377 ( 44 )	629 ( 41 )

No statistical analyses for this end point

Secondary: Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration

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End point title

Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration

End point description

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

End point type

Secondary

End point timeframe

From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

End point values	BMS-986158 0.75 mg	BMS-986158 1.25 mg	BMS-986158 2 mg	BMS-986158 3 mg	BMS-986158 4.5 mg
Number of subjects analysed	4	3	11	18	14
Units: hr
arithmetic mean (standard deviation)
Parent BMS-986158	33.7 ( 1.41 )	48.7 ( 6.66 )	54.3 ( 19.87 )	42.7 ( 19.56 )	43.8 ( 15.75 )
Metabolite BMT-161485	35.3 ( 99999 )	50.8 ( 6.26 )	48.8 ( 18.78 )	39.4 ( 13.80 )	38.7 ( 13.66 )

No statistical analyses for this end point

Secondary: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration

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End point title

Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration

End point description

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485

End point type

Secondary

End point timeframe

From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

End point values	BMS-986158 0.75 mg	BMS-986158 1.25 mg	BMS-986158 2 mg	BMS-986158 3 mg	BMS-986158 4.5 mg
Number of subjects analysed	4	3	11	18	14
Units: hr*ng/mL
geometric mean (geometric coefficient of variation)
Parent BMS-986158	2479 ( 18 )	7013 ( 17 )	9775 ( 56 )	11677 ( 44 )	18974 ( 40 )
Metabolite BMT-161485	409 ( 99999 )	892 ( 13 )	944 ( 73 )	1128 ( 46 )	2231 ( 67 )

No statistical analyses for this end point

Secondary: Apparent Total Body Clearance (CLT/F) - Single Dose Administration

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End point title

Apparent Total Body Clearance (CLT/F) - Single Dose Administration

End point description

Values are reported only for the parent BMS-986158

End point type

Secondary

End point timeframe

From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

End point values	BMS-986158 0.75 mg	BMS-986158 1.25 mg	BMS-986158 2 mg	BMS-986158 3 mg	BMS-986158 4.5 mg
Number of subjects analysed	5	3	16	25	17
Units: mL/min
geometric mean (geometric coefficient of variation)	5.04 ( 17 )	2.97 ( 18 )	3.41 ( 56 )	4.28 ( 62 )	3.95 ( 33 )

No statistical analyses for this end point

Secondary: Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration

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End point title

Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration

End point description

Values are reported only for the parent BMS-986158

End point type

Secondary

End point timeframe

From drug administration in Cycle 1 Day 1 to 168 hours post drug administration

End point values	BMS-986158 1.25 mg	BMS-986158 0.75 mg	BMS-986158 2 mg	BMS-986158 3 mg	BMS-986158 4.5 mg
Number of subjects analysed	3	4	11	18	14
Units: Liters
geometric mean (geometric coefficient of variation)	12.5 ( 18 )	14.7 ( 21 )	14.8 ( 27 )	14.4 ( 28 )	14.1 ( 31 )

No statistical analyses for this end point

Secondary: Maximum Observed Plasma Concentration (Cmax) - Multiple Dose Administration

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End point title

Maximum Observed Plasma Concentration (Cmax) - Multiple Dose Administration ^[12]

End point description

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)

End point type

Secondary

End point timeframe

From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Notes
[12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Not all the arms were assessed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg
Number of subjects analysed	5	4	9	10	10	1	4	6	11	7
Units: ng/mL
geometric mean (geometric coefficient of variation)
Parent BMS-986158 - Cycle 1 Day 1	68.8 ( 23 )	175 ( 36 )	260 ( 20 )	328 ( 36 )	478 ( 24 )	207 ( 99999 )	481 ( 25 )	295 ( 29 )	370 ( 22 )	567 ( 24 )
Parent BMS-986158 - Latest timepoint	136 ( 43 )	284 ( 16 )	442 ( 29 )	624 ( 44 )	898 ( 39 )	279 ( 99999 )	855 ( 99999 )	520 ( 34 )	588 ( 47 )	901 ( 62 )
Metabolite BMT-161485 - Cycle 1 Day 1	5.00 ( 30 )	10.0 ( 29 )	16.9 ( 32 )	22.5 ( 38 )	30.0 ( 41 )	13.6 ( 99999 )	26.3 ( 63 )	21.1 ( 35 )	19.4 ( 44 )	45.5 ( 32 )
Metabolite BMT-161485 -Latest timepoint	25.8 ( 82 )	31.0 ( 25 )	49.4 ( 46 )	83.3 ( 57 )	126 ( 50 )	32.7 ( 99999 )	127 ( 99999 )	80.7 ( 53 )	64.5 ( 55 )	146 ( 83 )

No statistical analyses for this end point

Secondary: Time to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose Administration

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End point title

Time to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose Administration ^[13]

End point description

End point type

Secondary

End point timeframe

From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Notes
[13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Not all the arms were assessed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg
Number of subjects analysed	5	4	9	10	10	1	4	6	11	7
Units: Hours
median (full range (min-max))
Parent BMS-986158 - Cycle 1 day 1	4.00 (2.00 to 4.02)	1.00 (1.00 to 2.00)	2.00 (1.00 to 4.03)	2.00 (0.983 to 6.15)	2.04 (1.00 to 4.03)	1.00 (1.00 to 1.00)	1.03 (1.00 to 4.03)	1.00 (0.500 to 2.03)	1.00 (0.500 to 2.02)	2.02 (1.00 to 4.00)
Parent BMS-986158 - Latest timepoint	3.14 (2.00 to 6.05)	1.50 (0.500 to 2.00)	2.00 (0.500 to 4.02)	2.01 (0.500 to 2.10)	2.00 (1.00 to 4.05)	1.00 (1.00 to 1.00)	1.00 (1.00 to 1.00)	1.00 (0.833 to 4.00)	1.66 (0.967 to 2.03)	2.00 (0.167 to 2.03)
Metabolite BMT-161485 - Cycle 1 Day 1	24.0 (2.55 to 24.2)	2.00 (2.00 to 24.0)	5.08 (2.00 to 72.0)	23.9 (0.983 to 48.0)	15.1 (1.00 to 48.0)	1.00 (1.00 to 1.00)	1.52 (1.00 to 47.4)	14.9 (1.00 to 71.5)	2.02 (1.00 to 48.0)	6.27 (1.00 to 45.6)
Metabolite BMT-161485 -Latest timepoint	24.0 (24.0 to 24.0)	4.00 (1.50 to 6.00)	2.07 (0 to 4.02)	2.01 (1.00 to 6.10)	4.00 (1.00 to 24.0)	1.00 (1.00 to 1.00)	1.00 (1.00 to 1.00)	4.08 (3.83 to 24.0)	4.00 (0 to 6.32)	4.00 (1.00 to 27.1)

No statistical analyses for this end point

Secondary: Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose Administration

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End point title

Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose Administration ^[14]

End point description

End point type

Secondary

End point timeframe

From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Notes
[14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Not all the arms were assessed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg
Number of subjects analysed	5	4	9	10	10	1	4	6	11	7
Units: h*ng/mL
geometric mean (geometric coefficient of variation)
Parent BMS-986158 - Cycle 1 day 1	2150 ( 15 )	6372 ( 14 )	8564 ( 48 )	10452 ( 50 )	19124 ( 46 )	5202 ( 99999 )	25852 ( 41 )	10931 ( 43 )	11493 ( 54 )	17220 ( 84 )
Parent BMS-986158 - Latest timepoint	3449 ( 93 )	4961 ( 73 )	7612 ( 71 )	13378 ( 77 )	29517 ( 36 )	6321 ( 99999 )	33978 ( 99999 )	19868 ( 45 )	18266 ( 97 )	19995 ( 135 )
Metabolite BMT-161485 - Cycle 1 day 1	314 ( 32 )	790 ( 14 )	992 ( 65 )	1305 ( 48 )	2748 ( 64 )	424 ( 99999 )	2467 ( 61 )	1895 ( 58 )	1219 ( 73 )	2645 ( 77 )
Metabolite BMT-161485 -Latest timepoint	1474 ( 89 )	691 ( 73 )	1110 ( 89 )	2925 ( 85 )	6691 ( 49 )	1000 ( 99999 )	7339 ( 99999 )	5022 ( 62 )	3458 ( 96 )	5719 ( 134 )

No statistical analyses for this end point

Secondary: Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose Administration

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End point title

Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose Administration ^[15]

End point description

End point type

Secondary

End point timeframe

From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Notes
[15] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Not all the arms were assessed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg
Number of subjects analysed	5	3	9	10	10	1	4	6	11	7
Units: h*ng/mL
geometric mean (geometric coefficient of variation)
Parent BMS-986158 - Cycle 1 day 1	1027 ( 16 )	2309 ( 13 )	3610 ( 22 )	4942 ( 43 )	6786 ( 24 )	2358 ( 99999 )	6921 ( 28 )	3660 ( 27 )	4468 ( 29 )	7418 ( 43 )
Parent BMS-986158 - Latest timepoint	2716 ( 51 )	3852 ( 99999 )	99999 ( 99999 )	9817 ( 56 )	14551 ( 32 )	3430 ( 99999 )	13305 ( 99999 )	8561 ( 36 )	8637 ( 71 )	11286 ( 104 )
Metabolite BMT-161485 - Cycle 1 Day 1	98.2 ( 34 )	188 ( 11 )	290 ( 22 )	404 ( 39 )	560 ( 42 )	191 ( 99999 )	439 ( 52 )	367 ( 36 )	337 ( 46 )	741 ( 38 )
Metabolite BMT-161485 -Latest timepoint	550 ( 81 )	500 ( 99999 )	99999 ( 99999 )	1746 ( 64 )	2649 ( 48 )	505 ( 99999 )	2551 ( 99999 )	1765 ( 51 )	1299 ( 63 )	2616 ( 102 )

No statistical analyses for this end point

Secondary: Minimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose Administration

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End point title

Minimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose Administration ^[16]

End point description

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are reported only for the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)

End point type

Secondary

End point timeframe

From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

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: Not all the arms were assessed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg
Number of subjects analysed	4	4	7	8	8	1	1	5	8	7
Units: ng/mL
geometric mean (geometric coefficient of variation)
Parent BMS-986158 - Latest timepoint	73.7 ( 45 )	141 ( 17 )	208 ( 53 )	227 ( 76 )	428 ( 41 )	85.1 ( 99999 )	435 ( 99999 )	270 ( 42 )	238 ( 94 )	253 ( 125 )
Metabolite BMT-161485 -Latest timepoint	16.4 ( 91 )	22.3 ( 22 )	33.7 ( 55 )	54.0 ( 73 )	89.6 ( 55 )	14.4 ( 99999 )	79.5 ( 99999 )	59.7 ( 54 )	44.2 ( 74 )	71.1 ( 115 )

No statistical analyses for this end point

Secondary: Concentration at the End of Dosing Interval (C24) - Multiple Dose Administration

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End point title

Concentration at the End of Dosing Interval (C24) - Multiple Dose Administration ^[17]

End point description

End point type

Secondary

End point timeframe

From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

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: Not all the arms were assessed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg
Number of subjects analysed	5	4	9	10	10	1	4	6	11	7
Units: ng/mL
geometric mean (geometric coefficient of variation)
Parent BMS-986158 - Cycle 1 Day 1	33.5 ( 18 )	67.4 ( 12 )	108 ( 36 )	143 ( 50 )	210 ( 32 )	66.1 ( 99999 )	232 ( 30 )	112 ( 33 )	125 ( 43 )	185 ( 68 )
Parent BMS-986158 - Latest timepoint	87.9 ( 63 )	116 ( 99999 )	99999 ( 99999 )	280 ( 64 )	461 ( 36 )	85.1 ( 99999 )	463 ( 99999 )	276 ( 45 )	244 ( 93 )	263 ( 131 )
Metabolite BMT-161485 - Cycle 1 Day 1	4.85 ( 29 )	7.92 ( 8 )	12.0 ( 37 )	18.8 ( 40 )	27.0 ( 44 )	5.23 ( 99999 )	19.0 ( 42 )	16.3 ( 37 )	12.9 ( 58 )	29.1 ( 53 )
Metabolite BMT-161485 -Latest timepoint	16.4 ( 91 )	22.3 ( 22 )	33.7 ( 55 )	54.0 ( 73 )	89.6 ( 55 )	14.4 ( 99999 )	104 ( 99999 )	69.4 ( 62 )	47.8 ( 74 )	84.5 ( 120 )

No statistical analyses for this end point

Secondary: Trough Observed Plasma Concentration (Ctrough) - Multiple Dose Administration

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End point title

Trough Observed Plasma Concentration (Ctrough) - Multiple Dose Administration ^[18]

End point description

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485. Values are also reported separately for the first and last collection

End point type

Secondary

End point timeframe

From Cycle (C)2 Day (D)2 to C2D5 (Schedule A) or from C2D14 to C4D8 (Schedule B) or from C2D7 to C8D8 (Schedule C)

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: Not all the arms were assessed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg
Number of subjects analysed	4	3	4	8	9	1	1	3	6	7
Units: ng/mL
geometric mean (geometric coefficient of variation)
Parent BMS-986158 - First collection	35.7 ( 25 )	79.6 ( 10 )	142 ( 51 )	138 ( 48 )	257 ( 27 )	109 ( 99999 )	435 ( 99999 )	242 ( 58 )	282 ( 98 )	284 ( 119 )
Parent BMS-986158 -Last collection	87.9 ( 63 )	116 ( 99999 )	99999 ( 99999 )	280 ( 64 )	461 ( 36 )	289 ( 99999 )	99999 ( 99999 )	69.1 ( 99999 )	370 ( 99999 )	99999 ( 99999 )
Metabolite BMT-161485 - First collection	7.78 ( 36 )	9.42 ( 19 )	11.4 ( 51 )	22.2 ( 48 )	36.5 ( 44 )	16.9 ( 99999 )	79.5 ( 99999 )	51.2 ( 68 )	49.4 ( 81 )	75.3 ( 110 )
Metabolite BMT-161485 - Last collection	25.8 ( 82 )	20.1 ( 99999 )	99999 ( 99999 )	65.8 ( 63 )	108 ( 47 )	36.4 ( 99999 )	99999 ( 99999 )	10.8 ( 99999 )	24.5 ( 99999 )	99999 ( 99999 )

No statistical analyses for this end point

Secondary: Accumulation Index (AI) - Multiple Dose Administration

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End point title

Accumulation Index (AI) - Multiple Dose Administration ^[19]

End point description

AI is defined as the ratio of an exposure measure at steady-state to that after the first dose. Reported exposure measures include Cmax, C24 and AUC24. Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.

End point type

Secondary

End point timeframe

Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)

Notes
[19] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Not all the arms were assessed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg
Number of subjects analysed	4	3	7	8	8	1	1	5	8	7
Units: Ratio
geometric mean (geometric coefficient of variation)
Parent BMS-986158 - Cmax	1.89 ( 20 )	1.72 ( 20 )	1.76 ( 34 )	1.94 ( 42 )	1.79 ( 29 )	1.35 ( 99999 )	2.37 ( 99999 )	1.65 ( 13 )	1.50 ( 38 )	1.59 ( 47 )
Parent BMS-986158 - C24	2.58 ( 51 )	99999 ( 99999 )	99999 ( 99999 )	1.79 ( 38 )	2.24 ( 29 )	1.29 ( 99999 )	3.05 ( 99999 )	2.55 ( 24 )	1.98 ( 54 )	1.42 ( 72 )
Parent BMS-986158 - AUC24	2.60 ( 35 )	99999 ( 99999 )	99999 ( 99999 )	1.95 ( 38 )	2.15 ( 23 )	1.45 ( 99999 )	2.78 ( 99999 )	2.34 ( 22 )	1.90 ( 46 )	1.52 ( 59 )
Metabolite BMT-161485 - Cmax	4.53 ( 54 )	3.44 ( 38 )	2.91 ( 27 )	3.46 ( 33 )	4.45 ( 30 )	2.40 ( 99999 )	6.35 ( 99999 )	4.12 ( 36 )	3.08 ( 59 )	3.21 ( 64 )
Metabolite BMT-161485 - C24	4.63 ( 58 )	99999 ( 99999 )	99999 ( 99999 )	3.18 ( 38 )	4.33 ( 39 )	2.76 ( 99999 )	6.23 ( 99999 )	4.46 ( 31 )	4.02 ( 42 )	2.91 ( 79 )
Metabolite BMT-161485 - AUC24	5.06 ( 45 )	99999 ( 99999 )	99999 ( 99999 )	4.20 ( 55 )	5.03 ( 34 )	2.64 ( 99999 )	6.85 ( 99999 )	4.66 ( 25 )	3.87 ( 54 )	3.53 ( 87 )

No statistical analyses for this end point

Secondary: Effective Elimination Half-Life (Effective T-HALF) - Multiple Dose Administration

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End point title

Effective Elimination Half-Life (Effective T-HALF) - Multiple Dose Administration ^[20]

End point description

Values are reported separately for the parent BMS-986158 and its metabolite BMT-161485.

End point type

Secondary

End point timeframe

Cycle 2 Day 5 (Schedule A) or Cycle 2 Day 14 (Schedule B) or Cycle 2 Day 7 (Schedule C)

Notes
[20] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Not all the arms were assessed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg
Number of subjects analysed	3	0 ^[21]	0 ^[22]	7	8	1	1	5	8	7
Units: Hours
arithmetic mean (standard deviation)
Parent BMS-986158	36.0 ( 15.99 )	( )	( )	25.7 ( 14.86 )	27.3 ( 8.72 )	14.4 ( 99999 )	37.3 ( 99999 )	31.6 ( 10.48 )	27.3 ( 15.15 )	27.6 ( 19.11 )
Metabolite BMT-161485	80.9 ( 40.42 )	( )	( )	72.1 ( 47.11 )	80.4 ( 29.59 )	35.2 ( 99999 )	105 ( 99999 )	72.7 ( 19.42 )	63.5 ( 39.53 )	72.8 ( 74.17 )

Notes
[21] - No participants analyzed in this cohort
[22] - No participants analyzed in this cohort

No statistical analyses for this end point

Secondary: Ratio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose Administration

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End point title

Ratio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose Administration ^[23]

End point description

Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)

End point type

Secondary

End point timeframe

From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Notes
[23] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Not all the arms were assessed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg
Number of subjects analysed	5	4	8	9	10	1	4	6	11	7
Units: Ratio
arithmetic mean (standard deviation)
Cycle 1 Day 1	0.073 ( 0.0104 )	0.057 ( 0.0052 )	0.068 ( 0.0204 )	0.078 ( 0.0268 )	0.068 ( 0.0303 )	0.066 ( 99999 )	0.059 ( 0.0247 )	0.077 ( 0.0373 )	0.056 ( 0.0187 )	0.083 ( 0.0209 )
Latest timepoint	0.179 ( 0.0726 )	0.112 ( 0.0329 )	0.115 ( 0.0290 )	0.144 ( 0.0528 )	0.142 ( 0.0260 )	0.117 ( 99999 )	0.149 ( 99999 )	0.163 ( 0.0536 )	0.115 ( 0.0371 )	0.173 ( 0.0576 )

No statistical analyses for this end point

Secondary: Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose Administration

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End point title

Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose Administration ^[24]

End point description

Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)

End point type

Secondary

End point timeframe

From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Notes
[24] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Not all the arms were assessed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg
Number of subjects analysed	5	4	8	9	10	1	4	6	11	7
Units: Ratio
arithmetic mean (standard deviation)
Cycle 1 Day 1	0.154 ( 0.0504 )	0.127 ( 0.0369 )	0.125 ( 0.0262 )	0.152 ( 0.0572 )	0.151 ( 0.0558 )	0.081 ( 99999 )	0.099 ( 0.0279 )	0.182 ( 0.0632 )	0.114 ( 0.0473 )	0.170 ( 0.0821 )
Latest timepoint	0.247 ( 0.1000 )	0.141 ( 0.0248 )	0.150 ( 0.0377 )	0.234 ( 0.0787 )	0.233 ( 0.0558 )	0.158 ( 99999 )	0.216 ( 99999 )	0.274 ( 0.1184 )	0.203 ( 0.0788 )	0.320 ( 0.1552 )

No statistical analyses for this end point

Secondary: Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration

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End point title

Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration ^[25]

End point description

End point type

Secondary

End point timeframe

Cycle 1 Day 1

Notes
[25] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Not all the arms were assessed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg
Number of subjects analysed	1	3	4	4	5	1	1	3	6	5
Units: Ratio
arithmetic mean (standard deviation)	0.177 ( 99999 )	0.131 ( 0.0426 )	0.120 ( 0.0286 )	0.158 ( 0.0307 )	0.164 ( 0.0809 )	0.080 ( 99999 )	0.106 ( 99999 )	0.139 ( 0.0401 )	0.103 ( 0.0357 )	0.184 ( 0.0947 )

No statistical analyses for this end point

Secondary: Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose Administration

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End point title

Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose Administration ^[26]

End point description

Values are reported separately for Cycle 1 Day 1 and the latest collection timepoint available (Cycle 2 Day 5 for Schedule A, Cycle 2 day 14 for Schedule B, Cycle 2 Day 7 for Schedule C)

End point type

Secondary

End point timeframe

From Cycle 1 Day 1 to Cycle 2 Day 5 (Schedule A) or to Cycle 2 Day 14 (Schedule B) or to Cycle 2 Day 7 (Schedule C)

Notes
[26] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Not all the arms were assessed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg
Number of subjects analysed	5	3	8	9	10	1	4	6	11	7
Units: Ratio
arithmetic mean (standard deviation)
Cycle 1 Day 1	0.099 ( 0.0290 )	0.081 ( 0.0055 )	0.086 ( 0.0208 )	0.097 ( 0.0425 )	0.087 ( 0.0347 )	0.081 ( 99999 )	0.066 ( 0.0221 )	0.102 ( 0.0178 )	0.080 ( 0.0283 )	0.108 ( 0.0445 )
Latest timepoint	0.213 ( 0.0786 )	0.130 ( 99999 )	99999 ( 99999 )	0.192 ( 0.0697 )	0.187 ( 0.0475 )	0.147 ( 99999 )	0.192 ( 99999 )	0.218 ( 0.0770 )	0.160 ( 0.0561 )	0.253 ( 0.1151 )

No statistical analyses for this end point

Secondary: Change From Baseline in Electrocardiogram Parameter QTcF

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End point title

Change From Baseline in Electrocardiogram Parameter QTcF ^[27]

End point description

QT Interval corrected for Fridericia's Formula. Change from baseline is calculated from pre-dose at the indicated timepoints.

End point type

Secondary

End point timeframe

From Cycle 1 Day 1 to last dosing day in Cycle 2 (C2D8 for Schedule A, C2D14 for Schedule B, C2D7 for Schedule C).

Notes
[27] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Not all the arms were assessed for this endpoint

End point values	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg
Number of subjects analysed	4	1	9	8	11	3	1	4	8	8
Units: msec
arithmetic mean (standard deviation)	-6.8 ( 11.63 )	-5.3 ( 99999 )	-3.3 ( 22.48 )	-5.4 ( 18.45 )	-10.2 ( 22.43 )	-10.7 ( 15.10 )	-16.7 ( 99999 )	-7.7 ( 10.98 )	14.3 ( 14.03 )	-0.6 ( 10.75 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Serious Adverse events and other adverse events were assessed from date of first dose to 30 days following date of last dose (up to approximately 29 months).

Adverse event reporting additional description

All treated participants

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

24.0

Reporting group title

Part 1 Schedule A - BMS-986158 0.75 mg

Reporting group description

Single dose of BMS-986158 at 0.75 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Reporting group title

Part 1 Schedule A - BMS-986158 1.25 mg

Reporting group description

Single dose of BMS-986158 at 1.25 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Reporting group title

Part 1 Schedule A - BMS-986158 4.5 mg

Reporting group description

Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Reporting group title

Part 1 Schedule A - BMS-986158 3 mg

Reporting group description

Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Reporting group title

Part 1 Schedule A - BMS-986158 2 mg

Reporting group description

Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 5 consecutive days, followed by a 2 days rest period, on a 28 days cycle

Reporting group title

Part 1 Schedule B - BMS-986158 2 mg

Reporting group description

Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle

Reporting group title

Part 1 Schedule B - BMS-986158 3 mg

Reporting group description

Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 14 consecutive days, followed by a 7 days rest period, on a 21 days cycle

Reporting group title

Part 1 Schedule C - BMS-986158 2 mg

Reporting group description

Single dose of BMS-986158 at 2 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle

Reporting group title

Part 1 Schedule C - BMS-986158 3 mg

Reporting group description

Single dose of BMS-986158 at 3 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle

Reporting group title

Part 1 Schedule C - BMS-986158 4.5 mg

Reporting group description

Single dose of BMS-986158 at 4.5 mg. Approximately 7 days later, BMS-986158 is administered at the same dose QD for 7 consecutive days, followed by a 14 days rest period, on a 21 days cycle

Reporting group title

Part 2 Schedule A

Reporting group description

Serious adverse events	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg	Part 2 Schedule A
Total subjects affected by serious adverse events
subjects affected / exposed	3 / 5 (60.00%)	3 / 4 (75.00%)	9 / 13 (69.23%)	7 / 10 (70.00%)	7 / 13 (53.85%)	2 / 4 (50.00%)	2 / 4 (50.00%)	4 / 6 (66.67%)	5 / 13 (38.46%)	3 / 10 (30.00%)	0 / 1 (0.00%)
number of deaths (all causes)	5	3	12	8	10	3	3	4	10	7	0
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	1 / 13 (7.69%)	3 / 10 (30.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 3	0 / 1	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 1	0 / 1	0 / 3	0 / 1	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0
Malignant pleural effusion
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Neoplasm malignant
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tumour pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vascular disorders
Hypotension
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Non-cardiac chest pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Reproductive system and breast disorders
Vaginal fistula
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vulvovaginal pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dyspnoea
subjects affected / exposed	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumothorax
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
Confusional state
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Femur fracture
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Myocardial infarction
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Cerebrovascular accident
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	2 / 13 (15.38%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Haemorrhage intracranial
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Seizure
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Thrombocytopenia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	2 / 4 (50.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	1 / 1	0 / 0	0 / 0	0 / 0	2 / 2	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ascites
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Duodenal obstruction
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	2 / 13 (15.38%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lower gastrointestinal haemorrhage
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	2 / 13 (15.38%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	1 / 2	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Small intestinal obstruction
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 6 (33.33%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	0 / 0	0 / 2	0 / 1	0 / 0	0 / 0	0 / 3	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Biliary obstruction
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Jaundice cholestatic
subjects affected / exposed	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Flank pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pathological fracture
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Pneumonia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	1 / 10 (10.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyelonephritis
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Upper respiratory tract infection
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
Dehydration
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

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

Non-serious adverse events	Part 1 Schedule A - BMS-986158 0.75 mg	Part 1 Schedule A - BMS-986158 1.25 mg	Part 1 Schedule A - BMS-986158 4.5 mg	Part 1 Schedule A - BMS-986158 3 mg	Part 1 Schedule A - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 2 mg	Part 1 Schedule B - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 2 mg	Part 1 Schedule C - BMS-986158 3 mg	Part 1 Schedule C - BMS-986158 4.5 mg	Part 2 Schedule A
Total subjects affected by non serious adverse events
subjects affected / exposed	5 / 5 (100.00%)	4 / 4 (100.00%)	13 / 13 (100.00%)	10 / 10 (100.00%)	12 / 13 (92.31%)	4 / 4 (100.00%)	4 / 4 (100.00%)	6 / 6 (100.00%)	13 / 13 (100.00%)	9 / 10 (90.00%)	1 / 1 (100.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Vascular disorders
Deep vein thrombosis
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	1	0	0	0
Flushing
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Hot flush
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	0	0	0
Hypertension
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	2 / 13 (15.38%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	2	0	0
Hypotension
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Raynaud's phenomenon
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	3 / 13 (23.08%)	2 / 10 (20.00%)	2 / 13 (15.38%)	0 / 4 (0.00%)	2 / 4 (50.00%)	1 / 6 (16.67%)	3 / 13 (23.08%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	4	2	2	0	2	1	3	0	0
Catheter site pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Chest discomfort
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	0	0
Chest pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	1	0	0	1	0	0	0
Chills
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Early satiety
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	1	0	0	1	0	0
Fatigue
subjects affected / exposed	3 / 5 (60.00%)	4 / 4 (100.00%)	5 / 13 (38.46%)	3 / 10 (30.00%)	8 / 13 (61.54%)	3 / 4 (75.00%)	1 / 4 (25.00%)	2 / 6 (33.33%)	5 / 13 (38.46%)	5 / 10 (50.00%)	0 / 1 (0.00%)
occurrences all number	3	5	6	3	8	3	1	2	7	7	0
Influenza like illness
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	1	0	0
Malaise
subjects affected / exposed	2 / 5 (40.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0	0	0
Mucosal inflammation
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	2	0	0	2	0	0	0	1	0
Non-cardiac chest pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Oedema peripheral
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	4 / 13 (30.77%)	0 / 10 (0.00%)	2 / 13 (15.38%)	0 / 4 (0.00%)	2 / 4 (50.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	5	0	2	0	2	0	1	1	0
Pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	2 / 10 (20.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	2	0	1	0	0	0	0	0
Pyrexia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	2	0	2	0
Suprapubic pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	1	1	0	0
Reproductive system and breast disorders
Intermenstrual bleeding
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Pelvic pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Vaginal discharge
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Vaginal haemorrhage
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Vulvovaginal pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	1 / 5 (20.00%)	1 / 4 (25.00%)	4 / 13 (30.77%)	2 / 10 (20.00%)	3 / 13 (23.08%)	2 / 4 (50.00%)	0 / 4 (0.00%)	2 / 6 (33.33%)	3 / 13 (23.08%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	1	5	2	3	5	0	2	3	0	0
Dysphonia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	1	0	0	0
Dyspnoea
subjects affected / exposed	0 / 5 (0.00%)	2 / 4 (50.00%)	5 / 13 (38.46%)	1 / 10 (10.00%)	3 / 13 (23.08%)	2 / 4 (50.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	6 / 13 (46.15%)	3 / 10 (30.00%)	0 / 1 (0.00%)
occurrences all number	0	2	7	1	3	2	1	0	6	3	0
Dyspnoea exertional
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Epistaxis
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	4 / 13 (30.77%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 1 (100.00%)
occurrences all number	0	0	5	0	0	1	0	0	0	0	1
Haemoptysis
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	2 / 13 (15.38%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	2	0	0	0	0	1	0
Nasal congestion
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Oropharyngeal pain
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	1	0	0	0	0	0	0	0	0
Pleural effusion
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Sinus congestion
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Wheezing
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	2 / 6 (33.33%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0	0	0
Psychiatric disorders
Anxiety
subjects affected / exposed	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	1	0	0	0
Insomnia
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	2 / 4 (50.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	2	0	0	0	1	0
Mood altered
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	1 / 5 (20.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	2 / 13 (15.38%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	1	0	1	0	0	0	0	0	2	1	0
Amylase increased
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 1 (100.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	4
Aspartate aminotransferase increased
subjects affected / exposed	1 / 5 (20.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	2 / 13 (15.38%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	2 / 13 (15.38%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	1	0	1	0	2	0	0	0	2	2	0
Blood albumin decreased
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Blood bilirubin increased
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	4 / 13 (30.77%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 1 (100.00%)
occurrences all number	0	0	4	0	0	0	0	0	0	0	8
Blood creatinine increased
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	1	0	0
Blood uric acid increased
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	1	0	0
Haemoglobin decreased
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
International normalised ratio increased
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	2 / 13 (15.38%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 1 (100.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	1
Lipase increased
subjects affected / exposed	3 / 5 (60.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	3	0	0	0	0	0	0	0	1	0	0
Lymphocyte count decreased
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Urine output decreased
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Weight decreased
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	5 / 13 (38.46%)	1 / 10 (10.00%)	1 / 13 (7.69%)	2 / 4 (50.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	3 / 13 (23.08%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	5	1	2	2	0	1	3	0	0
White blood cell count increased
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Injury, poisoning and procedural complications
Contusion
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	2 / 13 (15.38%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	2	0	0	2	0	0	0	0	0
Eye contusion
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Post procedural haematoma
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Post procedural haemorrhage
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Postoperative ileus
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Radiation retinopathy
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Transfusion reaction
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	1	0	0
Cardiac disorders
Atrial flutter
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Cardiomyopathy
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Sinus tachycardia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	1	0
Tachycardia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	1	0
Ventricular extrasystoles
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Nervous system disorders
Balance disorder
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Dizziness
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	2 / 4 (50.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	2 / 13 (15.38%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	2	0	0	2	0	0
Headache
subjects affected / exposed	0 / 5 (0.00%)	2 / 4 (50.00%)	2 / 13 (15.38%)	0 / 10 (0.00%)	4 / 13 (30.77%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	2	2	0	4	3	0	0	0	0	0
Dysgeusia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	5 / 13 (38.46%)	1 / 10 (10.00%)	0 / 13 (0.00%)	2 / 4 (50.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	6	1	0	2	0	0	1	0	0
Migraine
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Neuralgia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	1	0	0	0
Neuropathy peripheral
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	1 / 10 (10.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	1	0	1	0	0	0	0	0
Paraesthesia
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Parosmia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Presyncope
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Somnolence
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	9 / 13 (69.23%)	1 / 10 (10.00%)	3 / 13 (23.08%)	1 / 4 (25.00%)	1 / 4 (25.00%)	1 / 6 (16.67%)	4 / 13 (30.77%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	14	1	4	1	1	1	5	1	0
Leukopenia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 1 (100.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	0	3
Lymphopenia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	2	0	0	0	0	0	0	0	0
Neutropenia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	1 / 1 (100.00%)
occurrences all number	0	0	0	1	0	0	0	0	8	0	3
Thrombocytopenia
subjects affected / exposed	0 / 5 (0.00%)	2 / 4 (50.00%)	8 / 13 (61.54%)	6 / 10 (60.00%)	3 / 13 (23.08%)	2 / 4 (50.00%)	4 / 4 (100.00%)	0 / 6 (0.00%)	5 / 13 (38.46%)	3 / 10 (30.00%)	1 / 1 (100.00%)
occurrences all number	0	3	13	6	5	2	10	0	6	4	1
Ear and labyrinth disorders
External ear pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Meniere's disease
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Tinnitus
subjects affected / exposed	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Vertigo
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Eye disorders
Dry eye
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	1	0
Eye pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Eyelid oedema
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Lacrimation increased
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Vision blurred
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Vitreous floaters
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Gastrointestinal disorders
Abdominal discomfort
subjects affected / exposed	1 / 5 (20.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	1	0	0	0	0	0	1	1	0	0
Abdominal distension
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	2 / 13 (15.38%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	2	0	0	0	0	0	0
Abdominal pain
subjects affected / exposed	1 / 5 (20.00%)	1 / 4 (25.00%)	1 / 13 (7.69%)	1 / 10 (10.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	3 / 13 (23.08%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	2	3	1	1	1	0	1	0	4	1	0
Abdominal pain upper
subjects affected / exposed	3 / 5 (60.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	1 / 13 (7.69%)	1 / 4 (25.00%)	2 / 4 (50.00%)	0 / 6 (0.00%)	2 / 13 (15.38%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	3	0	1	0	1	1	2	0	2	0	0
Constipation
subjects affected / exposed	2 / 5 (40.00%)	2 / 4 (50.00%)	4 / 13 (30.77%)	0 / 10 (0.00%)	5 / 13 (38.46%)	1 / 4 (25.00%)	0 / 4 (0.00%)	2 / 6 (33.33%)	3 / 13 (23.08%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	2	2	5	0	6	1	0	3	4	0	0
Diarrhoea
subjects affected / exposed	3 / 5 (60.00%)	1 / 4 (25.00%)	10 / 13 (76.92%)	7 / 10 (70.00%)	6 / 13 (46.15%)	3 / 4 (75.00%)	2 / 4 (50.00%)	4 / 6 (66.67%)	8 / 13 (61.54%)	7 / 10 (70.00%)	1 / 1 (100.00%)
occurrences all number	4	1	15	9	8	7	2	5	11	8	1
Dry mouth
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	3 / 13 (23.08%)	1 / 10 (10.00%)	1 / 13 (7.69%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	1	3	1	1	1	0	0	1	2	0
Dyspepsia
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	2	0	0	0	2	0	0	1	2	0
Dysphagia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Eructation
subjects affected / exposed	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	1	0	0	0	0	0	0
Flatulence
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	1	0	0	0	2	0
Gingival pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Haemorrhoidal haemorrhage
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Melaena
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Nausea
subjects affected / exposed	3 / 5 (60.00%)	2 / 4 (50.00%)	6 / 13 (46.15%)	3 / 10 (30.00%)	8 / 13 (61.54%)	1 / 4 (25.00%)	0 / 4 (0.00%)	6 / 6 (100.00%)	7 / 13 (53.85%)	5 / 10 (50.00%)	0 / 1 (0.00%)
occurrences all number	7	4	8	3	14	1	0	6	12	7	0
Small intestinal obstruction
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	1	0	0	0
Stomatitis
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Vomiting
subjects affected / exposed	3 / 5 (60.00%)	3 / 4 (75.00%)	6 / 13 (46.15%)	2 / 10 (20.00%)	7 / 13 (53.85%)	1 / 4 (25.00%)	1 / 4 (25.00%)	5 / 6 (83.33%)	5 / 13 (38.46%)	3 / 10 (30.00%)	0 / 1 (0.00%)
occurrences all number	5	5	10	2	10	2	1	6	9	5	0
Hepatobiliary disorders
Hepatic pain
subjects affected / exposed	1 / 5 (20.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0	0	0
Hepatomegaly
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Hyperbilirubinaemia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	3 / 4 (75.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	3	0	0	3	0
Jaundice
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Skin and subcutaneous tissue disorders
Alopecia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Decubitus ulcer
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	0	0	0
Dermatitis acneiform
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 1 (100.00%)
occurrences all number	0	0	2	0	0	1	0	0	0	0	2
Dry skin
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	4 / 10 (40.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	4	1	0	0	0	0	1	0
Erythema
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Hyperhidrosis
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Hyperkeratosis
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Nail disorder
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Night sweats
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Photosensitivity reaction
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Pruritus
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	2 / 10 (20.00%)	1 / 13 (7.69%)	1 / 4 (25.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 1 (100.00%)
occurrences all number	0	0	1	2	1	1	1	0	0	0	1
Rash
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	3 / 13 (23.08%)	1 / 10 (10.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	2 / 4 (50.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	4	1	1	0	2	0	0	1	0
Rash maculo-papular
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	2 / 13 (15.38%)	1 / 10 (10.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	2	1	0	0	1	0	0	0	0
Skin disorder
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Chromaturia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	1	1	0
Chronic kidney disease
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Dysuria
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	2 / 13 (15.38%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	2	0	0
Hydronephrosis
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Pollakiuria
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	1	0
Urinary retention
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	1	0	0	0	0	0	0
Arthritis
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Back pain
subjects affected / exposed	2 / 5 (40.00%)	1 / 4 (25.00%)	3 / 13 (23.08%)	0 / 10 (0.00%)	1 / 13 (7.69%)	2 / 4 (50.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	1 / 13 (7.69%)	2 / 10 (20.00%)	0 / 1 (0.00%)
occurrences all number	2	1	3	0	1	2	0	1	1	2	0
Flank pain
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	1	0	0	0	1	0	0
Groin pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	1	0	0	0
Muscle spasms
subjects affected / exposed	1 / 5 (20.00%)	1 / 4 (25.00%)	3 / 13 (23.08%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	2 / 10 (20.00%)	0 / 1 (0.00%)
occurrences all number	1	1	3	0	1	0	0	0	0	2	0
Musculoskeletal chest pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	2 / 13 (15.38%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	3	0	0	1	1	0	0
Myalgia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	1	1	0	0
Neck pain
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	1 / 10 (10.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	1	0	0	0	0	0	0	0
Pain in extremity
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Pain in jaw
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Infections and infestations
Abdominal infection
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0	0	0
Bronchitis
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0	0	0
Candida infection
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Enteritis infectious
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Herpes zoster
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 1 (100.00%)
occurrences all number	0	0	0	1	0	0	1	0	0	0	1
Influenza
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	2 / 13 (15.38%)	1 / 10 (10.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	2	1	0	0	0	0	0	0	0
Localised infection
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Oral herpes
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Paronychia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	0	1	0
Pneumonia
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	1	0	0	0	0	0	0	0	0	0
Pyuria
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0	0	0
Tooth infection
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Upper respiratory tract infection
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	2 / 13 (15.38%)	1 / 10 (10.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	2	1	0	1	0	0	0	0	0
Urinary tract infection
subjects affected / exposed	1 / 5 (20.00%)	1 / 4 (25.00%)	3 / 13 (23.08%)	0 / 10 (0.00%)	1 / 13 (7.69%)	1 / 4 (25.00%)	1 / 4 (25.00%)	2 / 6 (33.33%)	2 / 13 (15.38%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	1	1	3	0	1	1	1	2	2	0	0
Urosepsis
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Vaginal infection
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	0	1	0	0
Viral infection
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Viral upper respiratory tract infection
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0	0	0
Metabolism and nutrition disorders
Appetite disorder
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	1 / 6 (16.67%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0	0	0
Decreased appetite
subjects affected / exposed	2 / 5 (40.00%)	3 / 4 (75.00%)	7 / 13 (53.85%)	3 / 10 (30.00%)	6 / 13 (46.15%)	2 / 4 (50.00%)	2 / 4 (50.00%)	3 / 6 (50.00%)	3 / 13 (23.08%)	3 / 10 (30.00%)	0 / 1 (0.00%)
occurrences all number	2	5	8	3	9	2	2	4	3	7	0
Dehydration
subjects affected / exposed	0 / 5 (0.00%)	1 / 4 (25.00%)	1 / 13 (7.69%)	1 / 10 (10.00%)	2 / 13 (15.38%)	1 / 4 (25.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	2 / 10 (20.00%)	0 / 1 (0.00%)
occurrences all number	0	3	1	1	2	1	0	0	0	3	0
Gout
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	0	0
Hyperglycaemia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	1	0	1	0	0	0	0
Hyperkalaemia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	0	1	0	0	0	0	0	0
Hypoalbuminaemia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 1 (0.00%)
occurrences all number	0	0	0	0	0	0	1	0	0	1	0
Hypocalcaemia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	0 / 13 (0.00%)	1 / 10 (10.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	1 / 1 (100.00%)
occurrences all number	0	0	0	1	0	0	0	0	1	0	1
Hypokalaemia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	2 / 10 (20.00%)	0 / 13 (0.00%)	0 / 4 (0.00%)	1 / 4 (25.00%)	1 / 6 (16.67%)	2 / 13 (15.38%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	2	0	0	1	1	3	0	0
Hypomagnesaemia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	3 / 13 (23.08%)	2 / 10 (20.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	2 / 13 (15.38%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	3	2	1	0	0	0	2	0	0
Hyponatraemia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	1 / 10 (10.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	0 / 4 (0.00%)	0 / 6 (0.00%)	0 / 13 (0.00%)	0 / 10 (0.00%)	0 / 1 (0.00%)
occurrences all number	0	0	1	2	1	0	0	0	0	0	0
Hypophosphataemia
subjects affected / exposed	0 / 5 (0.00%)	0 / 4 (0.00%)	1 / 13 (7.69%)	0 / 10 (0.00%)	1 / 13 (7.69%)	0 / 4 (0.00%)	1 / 4 (25.00%)	0 / 6 (0.00%)	1 / 13 (7.69%)	1 / 10 (10.00%)	1 / 1 (100.00%)
occurrences all number	0	0	2	0	1	0	1	0	1	1	1

More information

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Were there any global substantial amendments to the protocol? Yes

12 Apr 2016

Study design updates

06 Sep 2017

Study design updates

01 Mar 2018

Updates to Exclusion Criteria

17 Jul 2018

PK Sample collection schedule updates

18 Mar 2019

Study design updates

Were there any global interruptions to the trial? No

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

None reported

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Clinical trials

Clinical Trial Results: A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, as Monotherapy or in Combination with Nivolumab in Subjects with Selected Advanced Solid Tumors or Hematologic Malignancies

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Number of Participants Experiencing Adverse Events

Primary: Number of Participants Experiencing Adverse Events

Primary: Number of Participants With Abnormal Hepatic Test Values

Primary: Number of Participants With Abnormal Hepatic Test Values

Secondary: Best Overall Response (BOR)

Secondary: Best Overall Response (BOR)

Secondary: Objective Response Rate (ORR)

Secondary: Objective Response Rate (ORR)

Secondary: Duration of Response (DOR)

Secondary: Duration of Response (DOR)

Secondary: Progression Free Survival (PFS)

Secondary: Progression Free Survival (PFS)

Secondary: Progression Free Survival Rate (PFSR)

Secondary: Progression Free Survival Rate (PFSR)

Secondary: Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration

Secondary: Maximum Observed Plasma Concentration (Cmax) - Single Dose Administration

Secondary: Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration

Secondary: Time of Maximum Observed Plasma Concentration (Tmax) - Single Dose Administration

Secondary: Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration

Secondary: Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Single Dose Administration

Secondary: Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration

Secondary: Apparent Terminal Phase Half-Life (T-HALF) - Single Dose Administration

Secondary: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration

Secondary: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) - Single Dose Administration

Secondary: Apparent Total Body Clearance (CLT/F) - Single Dose Administration

Secondary: Apparent Total Body Clearance (CLT/F) - Single Dose Administration

Secondary: Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration

Secondary: Apparent Volume of Distribution of Terminal Phase (Vz/F) - Single Dose Administration

Secondary: Maximum Observed Plasma Concentration (Cmax) - Multiple Dose Administration

Secondary: Maximum Observed Plasma Concentration (Cmax) - Multiple Dose Administration

Secondary: Time to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose Administration

Secondary: Time to Maximum Observed Plasma Concentration (Tmax) - Multiple Dose Administration

Secondary: Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose Administration

Secondary: Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) - Multiple Dose Administration

Secondary: Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose Administration

Secondary: Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) - Multiple Dose Administration

Secondary: Minimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose Administration

Secondary: Minimum Observed Concentration Within a Dosing Interval (Cmin) - Multiple Dose Administration

Secondary: Concentration at the End of Dosing Interval (C24) - Multiple Dose Administration

Secondary: Concentration at the End of Dosing Interval (C24) - Multiple Dose Administration

Secondary: Trough Observed Plasma Concentration (Ctrough) - Multiple Dose Administration

Secondary: Trough Observed Plasma Concentration (Ctrough) - Multiple Dose Administration

Secondary: Accumulation Index (AI) - Multiple Dose Administration

Secondary: Accumulation Index (AI) - Multiple Dose Administration

Secondary: Effective Elimination Half-Life (Effective T-HALF) - Multiple Dose Administration

Secondary: Effective Elimination Half-Life (Effective T-HALF) - Multiple Dose Administration

Secondary: Ratio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose Administration

Secondary: Ratio of Metabolite (BMT-161485) Maximum Observed Plasma Concentration (Cmax) to Parent (BMS-986158) Cmax - Multiple Dose Administration

Secondary: Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose Administration

Secondary: Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero to Time of Last Quantifiable Concentration (AUC(0-T)) to Parent (BMS-986158) AUC(0-T) - Multiple Dose Administration

Secondary: Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration

Secondary: Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUC(INF)) to Parent (BMS-986158) AUC(INF) - Multiple Dose Administration

Secondary: Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose Administration

Secondary: Ratio of Metabolite (BMT-161485) Area Under the Plasma Concentration-Time Curve in One Dosing Interval (AUC(0-24)) to Parent (BMS-986158) AUC(0-24) - Multiple Dose Administration

Secondary: Change From Baseline in Electrocardiogram Parameter QTcF

Secondary: Change From Baseline in Electrocardiogram Parameter QTcF

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase I/IIa Trial With BMS-986158, a Small Molecule Inhibitor of the Bromodomain and Extra-Terminal (BET) Proteins, as Monotherapy or in Combination with Nivolumab in Subjects with Selected Advanced Solid Tumors or Hematologic Malignancies