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Clinical Trial Results:
A Phase I/IIa Study of BMS 986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects with Select Advanced Solid Tumors

Summary
EudraCT number	2014-002485-70
Trial protocol	NL BE GB
Global end of trial date	07 May 2020

Results information
Results version number	v1(current)
This version publication date	09 Apr 2022
First version publication date	09 Apr 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

CA008-002

ISRCTN number

US NCT number

NCT02341625

WHO universal trial number (UTN)

U1111-1165-9742

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

07 May 2020

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

07 May 2020

Was the trial ended prematurely?

Yes

Main objective of the trial

To assess the safety and tolerability of BMS-986148 in subjects with select advanced solid tumors.

Protection of trial subjects

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

Netherlands: 13

Country: Number of subjects enrolled

United Kingdom: 1

Country: Number of subjects enrolled

Belgium: 30

Country: Number of subjects enrolled

Italy: 9

Country: Number of subjects enrolled

Australia: 23

Country: Number of subjects enrolled

Canada: 28

Country: Number of subjects enrolled

United States: 22

Worldwide total number of subjects

126

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

126 participants 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

BMS-986148 0.1MG/KG Q3W

Arm description

Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986148

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

0.1MG/KG Q3W infused within 60 minutes

BMS-986148 0.2MG/KG Q3W

Arm description

Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986148

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

0.2MG/KG Q3W infused within 60 minutes

BMS-986148 0.4MG/KG Q3W

Arm description

Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986148

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

0.4MG/KG Q3W infused within 60 minutes

BMS-986148 0.8MG/KG Q3W

Arm description

Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986148

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

0.8MG/KG Q3W infused within 60 minutes

BMS-986148 1.2MG/KG Q3W Es

Arm description

Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W

Arm type

Experimental

Investigational medicinal product name

BMS-986148

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

1.2MG/KG Q3W infused within 60 minutes

BMS-986148 1.6MG/KG Q3W

Arm description

Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986148

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

1.6MG/KG Q3W infused within 60 minutes

BMS-986148 1.2MG/KG Q3W Ex

Arm description

Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer

Arm type

Experimental

Investigational medicinal product name

BMS-986148

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

1.2MG/KG Q3W infused within 60 minutes

BMS-986148 0.4MG/KG QW

Arm description

Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986148

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

0.4 MG/KG QW infused within 60 minutes

BMS-986148 0.6MG/KG QW

Arm description

Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle

Arm type

Experimental

Investigational medicinal product name

BMS-986148

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

0.6 MG/KG QW infused within 60 minutes

BMS-986148 0.8MG/KG Q3W+Nivolumab

Arm description

Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer

Arm type

Experimental

Investigational medicinal product name

Nivolumab

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

360mg as a 30-minute infusion on Day 1 of each 21-day treatment cycle

Investigational medicinal product name

BMS-986148

Investigational medicinal product code

Other name

Pharmaceutical forms

Injection

Routes of administration

Intravenous use

Dosage and administration details

0.8 MG/KG QW infused within 60 minutes

Number of subjects in period 1	BMS-986148 0.1MG/KG Q3W	BMS-986148 0.2MG/KG Q3W	BMS-986148 0.4MG/KG Q3W	BMS-986148 0.8MG/KG Q3W	BMS-986148 1.2MG/KG Q3W Es	BMS-986148 1.6MG/KG Q3W	BMS-986148 1.2MG/KG Q3W Ex	BMS-986148 0.4MG/KG QW	BMS-986148 0.6MG/KG QW	BMS-986148 0.8MG/KG Q3W+Nivolumab
Started	2	2	3	8	8	10	51	8	4	30
Completed	0	0	0	0	0	0	0	0	0	0
Not completed	2	2	3	8	8	10	51	8	4	30
Not Reported	-	-	-	-	-	-	-	-	-	3
Other Reasons	-	-	-	-	1	-	5	-	-	2
Participant Request to Discontinue Study Treatment	-	-	-	-	-	-	6	2	-	-
Completed Treatment as per Protocol	-	-	-	-	-	-	-	-	-	1
Adverse Event Unrelated to Study Drug	-	-	-	-	-	-	2	1	-	2
Study Drug Toxicity	-	-	-	1	-	3	10	-	-	3
Participant Withdrew Consent	-	-	-	1	-	-	-	-	-	-
Disease Progression	2	2	3	6	7	7	28	5	4	19

Baseline characteristics

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Reporting group title

BMS-986148 0.1MG/KG Q3W

Reporting group description

Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle

Reporting group title

BMS-986148 0.2MG/KG Q3W

Reporting group description

Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle

Reporting group title

BMS-986148 0.4MG/KG Q3W

Reporting group description

Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle

Reporting group title

BMS-986148 0.8MG/KG Q3W

Reporting group description

Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle

Reporting group title

BMS-986148 1.2MG/KG Q3W Es

Reporting group description

Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W

Reporting group title

BMS-986148 1.6MG/KG Q3W

Reporting group description

Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle

Reporting group title

BMS-986148 1.2MG/KG Q3W Ex

Reporting group description

Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer

Reporting group title

BMS-986148 0.4MG/KG QW

Reporting group description

Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle

Reporting group title

BMS-986148 0.6MG/KG QW

Reporting group description

Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle

Reporting group title

BMS-986148 0.8MG/KG Q3W+Nivolumab

Reporting group description

Reporting group values	BMS-986148 0.1MG/KG Q3W	BMS-986148 0.2MG/KG Q3W	BMS-986148 0.4MG/KG Q3W	BMS-986148 0.8MG/KG Q3W	BMS-986148 1.2MG/KG Q3W Es	BMS-986148 1.6MG/KG Q3W	BMS-986148 1.2MG/KG Q3W Ex	BMS-986148 0.4MG/KG QW	BMS-986148 0.6MG/KG QW	BMS-986148 0.8MG/KG Q3W+Nivolumab	Total
Number of subjects	2	2	3	8	8	10	51	8	4	30	126
Age categorical
Units: Subjects
In utero	0	0	0	0	0	0	0	0	0	0	0
Preterm newborn infants (gestational age < 37 wks)	0	0	0	0	0	0	0	0	0	0	0
Newborns (0-27 days)	0	0	0	0	0	0	0	0	0	0	0
Infants and toddlers (28 days-23 months)	0	0	0	0	0	0	0	0	0	0	0
Children (2-11 years)	0	0	0	0	0	0	0	0	0	0	0
Adolescents (12-17 years)	0	0	0	0	0	0	0	0	0	0	0
Adults (18-64 years)	2	0	2	4	5	7	27	4	3	19	73
From 65-84 years	0	2	1	4	3	3	24	4	1	11	53
85 years and over	0	0	0	0	0	0	0	0	0	0	0
Age Continuous
Units: Years
arithmetic mean (standard deviation)	59.5 ± 0.7	70.5 ± 0.7	65.3 ± 5.8	63.9 ± 5.4	63.4 ± 5.1	59.0 ± 16.0	61.5 ± 9.5	66.3 ± 8.6	64.5 ± 9.1	61.6 ± 9.4	-
Sex: Female, Male
Units: Participants
Female	0	0	2	3	3	3	31	3	2	12	59
Male	2	2	1	5	5	7	20	5	2	18	67
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	0	0	0	0	0	0	0	0	0
Asian	1	0	0	1	1	1	0	0	0	0	4
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0	0	0	0	0	0
Black or African American	0	0	0	0	0	0	2	0	1	0	3
White	1	2	3	7	7	9	46	8	3	30	116
More than one race	0	0	0	0	0	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0	3	0	0	0	3
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	0	1	0	0	0	0	0	0	0	0	1
Not Hispanic or Latino	2	1	3	8	8	10	46	8	3	25	114
Unknown or Not Reported	0	0	0	0	0	0	5	0	1	5	11

End points

Top of page

Reporting group title

BMS-986148 0.1MG/KG Q3W

Reporting group description

Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle

Reporting group title

BMS-986148 0.2MG/KG Q3W

Reporting group description

Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle

Reporting group title

BMS-986148 0.4MG/KG Q3W

Reporting group description

Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle

Reporting group title

BMS-986148 0.8MG/KG Q3W

Reporting group description

Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle

Reporting group title

BMS-986148 1.2MG/KG Q3W Es

Reporting group description

Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W

Reporting group title

BMS-986148 1.6MG/KG Q3W

Reporting group description

Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle

Reporting group title

BMS-986148 1.2MG/KG Q3W Ex

Reporting group description

Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer

Reporting group title

BMS-986148 0.4MG/KG QW

Reporting group description

Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle

Reporting group title

BMS-986148 0.6MG/KG QW

Reporting group description

Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle

Reporting group title

BMS-986148 0.8MG/KG Q3W+Nivolumab

Reporting group description

Subject analysis set title

BMS-986148 1.2MG/KG Q3W Es

Subject analysis set type

Full analysis

Subject analysis set description

Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W and Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer

Subject analysis set title

BMS 1.2MG/KG Q3W Ex

Subject analysis set type

Full analysis

Subject analysis set description

Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer

Subject analysis set title

BMS 0.8MG/KG Q3W+Nivolumab Es

Subject analysis set type

Full analysis

Subject analysis set description

Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle

Subject analysis set title

BMS 0.8MG/KG Q3W+Nivolumab Ex

Subject analysis set type

Full analysis

Subject analysis set description

Part 3B Dose Expansion: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer

Subject analysis set title

BMS-986148 Mesothelioma

Subject analysis set type

Full analysis

Subject analysis set description

Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.1 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer

Subject analysis set title

BMS-986148+Nivolumab Mesothelioma

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

BMS-986148 Ovarian

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

BMS-986148+Nivolumab Ovarian

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

BMS-986148 Pancreatic

Subject analysis set type

Full analysis

Subject analysis set description

Part 1A Dose Escalation: BMS-986148 starting with a dose of 0.8 mg/kg IV Q3W to a dose of 1.6 mg/kg IV Q3W in a 21-day cycle Part 1B Dose Escalation: BMS-986148 starting with a dose of 0.4 mg/kg IV QW to a dose of 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle Part 2 Dose Expansion: BMS-986148 1.2 mg/kg IV Q3W restricted to five tumor types: 1) mesothelioma; 2) pancreatic; 3) ovarian; 4) NSCLC; and 5) gastric cancer.

Subject analysis set title

BMS-986148+Nivolumab Pancreatic

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

BMS-986148 NSCLC

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

BMS-986148+Nivolumab NSCLC

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

BMS-986148 Gastric

Subject analysis set type

Full analysis

Subject analysis set description

Subject analysis set title

BMS-986148+Nivolumab Gastric

Subject analysis set type

Full analysis

Subject analysis set description

Primary: Incidence of Participants with Adverse Events at Worst CTC Grade

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End point title

Incidence of Participants with Adverse Events at Worst CTC Grade ^[1] ^[2]

End point description

Incidence of participants with adverse events at worst CTC grade including any grade adverse events (AEs), serious adverse events (SAEs), adverse events leading to discontinuations, and deaths grouped by dose + dose regimen.

End point type

Primary

End point timeframe

From first dose to up to 100 days post last dose (Up to 6 months)

Notes
[1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only summary statistics planned for this endpoint
[2] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Baseline period arm is reported within the subject analysis set

End point values	BMS-986148 0.1MG/KG Q3W	BMS-986148 0.2MG/KG Q3W	BMS-986148 0.4MG/KG Q3W	BMS-986148 0.8MG/KG Q3W	BMS-986148 1.6MG/KG Q3W	BMS-986148 0.4MG/KG QW	BMS-986148 0.6MG/KG QW	BMS-986148 0.8MG/KG Q3W+Nivolumab	BMS-986148 1.2MG/KG Q3W Es
Number of subjects analysed	2	2	3	8	10	8	4	30	59
Units: Participants
Adverse Events (AEs)	1	2	3	8	10	8	4	30	59
Serious Adverse Events (SAEs)	1	1	1	5	4	6	3	21	32
AEs Leading to Discontinuation	0	0	0	1	3	1	0	7	11
Deaths	1	2	3	5	7	7	4	22	38

No statistical analyses for this end point

Primary: Number of Participants with Laboratory Test Toxicity Grade Shifting from Baseline

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End point title

Number of Participants with Laboratory Test Toxicity Grade Shifting from Baseline ^[3] ^[4]

End point description

Number of participants with laboratory test toxicity grade (Grade 0, 1, 2, 3, and 4) in hematology and chemistry shifting from baseline. An increase in baseline indicates a shift of participant to a greater toxicity grade. A decrease in baseline indicates a shift of participant to a lesser toxicity grade. Participants are grouped by dose + dose regimen assessed by NCT CTCAE V 4.03.

End point type

Primary

End point timeframe

From first dose to up to 100 days post last dose (Up to 6 months)

Notes
[3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
Justification: Only summary statistics planned for this endpoint
[4] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Baseline period arm is reported within the subject analysis set

End point values	BMS-986148 0.1MG/KG Q3W	BMS-986148 0.2MG/KG Q3W	BMS-986148 0.4MG/KG Q3W	BMS-986148 0.8MG/KG Q3W	BMS-986148 1.6MG/KG Q3W	BMS-986148 0.4MG/KG QW	BMS-986148 0.6MG/KG QW	BMS-986148 0.8MG/KG Q3W+Nivolumab	BMS-986148 1.2MG/KG Q3W Es
Number of subjects analysed	2	2	3	8	10	8	4	30	59
Units: Participants
Hemoglobin increase from baseline	1	1	0	3	3	2	1	12	20
Hemoglobin decrease from baseline	0	0	1	1	0	0	0	0	3
Platelet Count increase from baseline	0	0	0	3	4	0	1	6	14
Platelet Count decrease from baseline	0	0	0	0	0	0	0	0	0
Leukocytes increase from baseline	0	0	1	0	2	1	0	2	1
Leukocytes decrease from baseline	0	0	0	0	0	1	0	0	1
Neutrophils increase from baseline	0	0	0	0	1	0	0	1	3
Neutrophils decrease from baseline	0	0	0	0	0	0	0	0	1
Lymphocytes increase from baseline	1	2	1	3	6	6	3	19	27
Lymphocytes decrease from baseline	0	0	1	0	0	1	0	0	0
Absolute Neutrophil increase from baseline	0	0	0	0	2	0	0	2	3
Absolute Neutrophil decrease from baseline	0	0	0	0	0	0	0	0	1
ALP increase from baseline	0	1	1	6	10	5	4	24	46
ALP decrease from baseline	0	0	0	0	0	0	0	0	0
AST increase from baseline	0	1	1	6	10	6	4	26	53
AST decrease from baseline	0	0	0	0	0	0	0	0	0
ALT increase from baseline	0	0	0	7	10	5	3	25	50
ALT decrease from baseline	0	0	0	0	0	0	0	0	1
Bilirubin increase from baseline	0	1	0	2	3	2	2	7	16
Bilirubin decrease from baseline	0	0	0	0	0	0	0	0	0
Creatinine increase from baseline	0	0	1	2	2	1	3	5	7
Creatinine decrease from baseline	0	0	0	0	0	0	0	0	0
Sodium increase from baseline	0	1	1	4	4	1	2	17	23
Sodium decrease from baseline	1	0	0	0	0	0	0	0	0
Potassium increase from baseline	1	0	0	3	5	1	2	9	24
Potassium decrease from baseline	0	1	0	0	0	0	0	0	3
Calcium Total increase from baseline	0	0	0	5	4	3	1	10	17
Calcium Total decrease from baseline	0	0	0	0	0	0	0	1	0
Calcium Corrected increase from baseline	0	0	0	2	1	0	0	1	0
Calcium Corrected decrease from baseline	0	0	0	0	0	0	0	0	0
Phosphorus increase from baseline	2	0	2	3	4	1	2	7	24
Phosphorus decrease from baseline	0	0	0	0	0	1	0	0	0
Magnesium increase from baseline	0	1	1	2	4	1	2	5	22
Magnesium decrease from baseline	0	0	0	0	0	0	0	1	3
Glucose Fasting Serum increase from baseline	0	0	0	0	0	0	1	5	6
Glucose Fasting Serum decrease from baseline	0	0	0	0	0	0	0	1	1
Albumin increase from baseline	0	1	0	7	8	6	2	19	37
Albumin decrease from baseline	0	0	0	0	0	0	0	0	0
Amylase increase from baseline	0	0	0	0	0	0	0	1	0
Amylase decrease from baseline	0	0	0	0	0	0	0	0	0
Lipase increase from baseline	0	0	0	0	0	0	0	1	0
Lipase decrease from baseline	0	0	0	0	0	0	0	0	0
Creatine Kinase increase from baseline	0	0	1	0	0	0	0	3	9
Creatine Kinase decrease from baseline	0	0	0	0	0	0	0	0	1
Uric Acid increase from baseline	0	0	1	1	2	0	2	6	6
Uric Acid decrease from baseline	0	0	0	0	0	0	0	0	0

No statistical analyses for this end point

Secondary: Maximum Observed Serum Concentration (Cmax)

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End point title

Maximum Observed Serum Concentration (Cmax) ^[5]

End point description

Maximum observed serum concentration (Cmax) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.

End point type

Secondary

End point timeframe

PK blood assessed on cycle 1, day 1

Notes
[5] - 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: Baseline period arm is reported within the subject analysis set

End point values	BMS-986148 0.1MG/KG Q3W	BMS-986148 0.2MG/KG Q3W	BMS-986148 0.4MG/KG Q3W	BMS-986148 0.8MG/KG Q3W	BMS-986148 1.2MG/KG Q3W Es	BMS-986148 1.6MG/KG Q3W	BMS-986148 0.4MG/KG QW	BMS-986148 0.6MG/KG QW	BMS 1.2MG/KG Q3W Ex	BMS 0.8MG/KG Q3W+Nivolumab Es	BMS 0.8MG/KG Q3W+Nivolumab Ex
Number of subjects analysed	2 ^[6]	2 ^[7]	3 ^[8]	8 ^[9]	8 ^[10]	10 ^[11]	8 ^[12]	4 ^[13]	49 ^[14]	11 ^[15]	17 ^[16]
Units: ug/mL
geometric mean (geometric coefficient of variation)
Total Antibody	2.3 ± 31.4	2.8 ± 7.6	3.3 ± 76.7	16.4 ± 47.2	28.5 ± 14.0	39.8 ± 24.5	9.3 ± 21.3	14.5 ± 22.3	28.3 ± 22.5	16.7 ± 19.7	18.8 ± 22.4
Active Antibody-Drug Conjugate (ADC)	2.0 ± 29.8	2.2 ± 8.2	2.6 ± 76.1	15.8 ± 46.4	27.0 ± 18.6	40.0 ± 26.3	8.8 ± 20.3	13.6 ± 31.0	27.5 ± 22.6	15.3 ± 27.6	17.8 ± 24.6
Unconjugated Tubulysin	99999 ± 99999	99999 ± 99999	0.5 ± 99999	0.2 ± 17.1	0.4 ± 70.9	0.4 ± 52.3	0.1 ± 36.0	0.4 ± 75.0	0.3 ± 58.2	0.2 ± 42.5	0.2 ± 42.5

Notes
[6] - Unconjugated Tubulysin = 0 participants analyzed
[7] - Unconjugated Tubulysin = 0 participants analyzed
[8] - Unconjugated Tubulysin =1 participants analyzed
[9] - Unconjugated Tubulysin = 4 participants analyzed
[10] - Total antibody and ADC = 7 participants analyzed
[11] - Unconjugated Tubulysin = 9 participants analyzed
[12] - Unconjugated Tubulysin = 2 participants analyzed
[13] - Unconjugated Tubulysin = 2 participants analyzed
[14] - Unconjugated Tubulysin = 45 participants analyzed
[15] - Unconjugated Tubulysin = 5 participants analyzed
[16] - Unconjugated Tubulysin = 11 participants analyzed

No statistical analyses for this end point

Secondary: Time of Maximum Observed Serum Concentration (Tmax)

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End point title

Time of Maximum Observed Serum Concentration (Tmax) ^[17]

End point description

Time of maximum observed serum concentration (Tmax) of BMS-986148 grouped by dose + dose regimen.

End point type

Secondary

End point timeframe

PK blood assessed on cycle 1, day 1

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: Baseline period arm is reported within the subject analysis set

End point values	BMS-986148 0.1MG/KG Q3W	BMS-986148 0.2MG/KG Q3W	BMS-986148 0.4MG/KG Q3W	BMS-986148 0.8MG/KG Q3W	BMS-986148 1.2MG/KG Q3W Es	BMS-986148 1.6MG/KG Q3W	BMS-986148 0.4MG/KG QW	BMS-986148 0.6MG/KG QW	BMS 1.2MG/KG Q3W Ex	BMS 0.8MG/KG Q3W+Nivolumab Es	BMS 0.8MG/KG Q3W+Nivolumab Ex
Number of subjects analysed	2 ^[18]	2 ^[19]	3 ^[20]	8 ^[21]	8 ^[22]	10 ^[23]	8 ^[24]	4 ^[25]	49 ^[26]	11 ^[27]	17 ^[28]
Units: Hours
median (full range (min-max))
Total Antibody	2.2 (0.3 to 4.0)	2.2 (0.3 to 4.1)	3.9 (0.5 to 4.7)	4.0 (0.2 to 4.8)	4.1 (1.1 to 4.1)	3.9 (0.9 to 4.3)	4.0 (0.6 to 4.1)	3.8 (1.1 to 3.9)	4.0 (0.8 to 24.1)	1.1 (0.6 to 24.1)	4.0 (0.9 to 23.8)
Active Antibody-Drug Conjugate (ADC)	0.2 (0.1 to 0.3)	2.2 (0.3 to 4.1)	0.5 (0.1 to 3.9)	2.5 (0.2 to 4.0)	3.8 (1.0 to 4.1)	1.5 (0.8 to 4.3)	4.0 (0.6 to 4.1)	3.8 (1.1 to 3.9)	3.9 (0.8 to 4.7)	1.0 (0.6 to 4.2)	4.0 (0.9 to 4.0)
Unconjugated Tubulysin	99999 (99999 to 99999)	99999 (99999 to 99999)	25.5 (25.5 to 25.5)	120.2 (71.8 to 169.7)	168.8 (48.0 to 335.5)	167.3 (71.4 to 170.0)	168.2 (166.9 to 169.4)	166.7 (94.7 to 238.7)	166.1 (24.3 to 338.8)	165.1 (48.0 to 170.9)	166.5 (47.8 to 335.9)

Notes
[18] - Unconjugated Tubulysin = 0 participants analyzed
[19] - Unconjugated Tubulysin = 0 participants analyzed
[20] - Unconjugated Tubulysin = 1 participants analyzed
[21] - Unconjugated Tubulysin = 4 participants analyzed
[22] - Total antibody and ADC = 7 participants analyzed
[23] - Unconjugated Tubulysin = 9 participants analyzed
[24] - Unconjugated Tubulysin = 2 participants analyzed
[25] - Unconjugated Tubulysin = 2 participants analyzed
[26] - Unconjugated Tubulysin = 45 participants analyzed
[27] - Unconjugated Tubulysin = 5 participants analyzed
[28] - Unconjugated Tubulysin = 11 participants analyzed

No statistical analyses for this end point

Secondary: Concentration at the End of a Dosing Interval (Ctau)

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End point title

Concentration at the End of a Dosing Interval (Ctau) ^[29]

End point description

Concentration at the end of a dosing interval (Ctau) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.

End point type

Secondary

End point timeframe

PK blood assessed on cycle 1, day 1

Notes
[29] - 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: Baseline period arm is reported within the subject analysis set

End point values	BMS-986148 0.1MG/KG Q3W	BMS-986148 0.2MG/KG Q3W	BMS-986148 0.4MG/KG Q3W	BMS-986148 0.8MG/KG Q3W	BMS-986148 1.2MG/KG Q3W Es	BMS-986148 1.6MG/KG Q3W	BMS-986148 0.4MG/KG QW	BMS-986148 0.6MG/KG QW	BMS 1.2MG/KG Q3W Ex	BMS 0.8MG/KG Q3W+Nivolumab Es	BMS 0.8MG/KG Q3W+Nivolumab Ex
Number of subjects analysed	2 ^[30]	2 ^[31]	2 ^[32]	8 ^[33]	7 ^[34]	10 ^[35]	8 ^[36]	3 ^[37]	46 ^[38]	10 ^[39]	17 ^[40]
Units: ug/mL
geometric mean (geometric coefficient of variation)
Total Antibody	0.0035 ± 112.0	0.0333 ± 115.7	0.8233 ± 131.8	0.4426 ± 106.1	1.0917 ± 91.9	1.4101 ± 101.8	3.2035 ± 20.2	3.8872 ± 46.1	1.1938 ± 98.7	0.2133 ± 114.0	0.7544 ± 83.5
Active Antibody-Drug Conjugate (ADC)	0.0633 ± 141.3	99999 ± 99999	0.0058 ± 99999	0.0309 ± 123.8	0.2121 ± 111.3	0.3049 ± 110.0	1.2705 ± 39.5	1.9068 ± 59.1	0.1558 ± 123.4	0.1119 ± 187.1	0.0797 ± 103.7
Unconjugated Tubulysin	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	0.2590 ± 77.1	0.1630 ± 0.9	0.1388 ± 36.0	0.3539 ± 75.0	0.1634 ± 48.2	99999 ± 99999	0.1330 ± 99999

Notes
[30] - Unconjugated Tubulysin = 0 participants analyzed
[31] - Unconjugated Tubulysin and ADC = 0 participants analyzed
[32] - ADC = 1 participant analyzed Unconjugated Tubulysin = 0 participants analyzed
[33] - Unconjugated Tubulysin = 0 participants analyzed
[34] - Unconjugated Tubulysin = 3 participants analyzed
[35] - Total antibody - 8 participants analyzed Unconjugated Tubulysin = 2 participants analyzed
[36] - Unconjugated Tubulysin = 2 participants analyzed
[37] - Unconjugated Tubulysin = 2 participants analyzed
[38] - Unconjugated Tubulysin = 6 participants analyzed
[39] - Total antibody = 9 participants analyzed Unconjugated Tubulysin = 0 participants analyzed
[40] - Unconjugated Tubulysin = 1 participant analyzed

No statistical analyses for this end point

Secondary: Trough Observed Serum Concentration (Ctrough)

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End point title

Trough Observed Serum Concentration (Ctrough) ^[41]

End point description

Trough observed serum concentration (Ctrough) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.

End point type

Secondary

End point timeframe

PK blood assessment include cycle 2-day 1 and cycle 1-day 8

Notes
[41] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Baseline period arm is reported within the subject analysis set

End point values	BMS-986148 0.1MG/KG Q3W	BMS-986148 0.2MG/KG Q3W	BMS-986148 0.4MG/KG Q3W	BMS-986148 0.8MG/KG Q3W	BMS-986148 1.2MG/KG Q3W Es	BMS-986148 1.6MG/KG Q3W	BMS-986148 0.4MG/KG QW	BMS-986148 0.6MG/KG QW	BMS 1.2MG/KG Q3W Ex	BMS 0.8MG/KG Q3W+Nivolumab Es	BMS 0.8MG/KG Q3W+Nivolumab Ex
Number of subjects analysed	2	2	3	7	8	6	8	3	39	10	13
Units: ug/mL
geometric mean (geometric coefficient of variation)
Total Antibody	0.1 ± 0.0	0.1 ± 0.00	0.1 ± 0.00	0.79676 ± 92.4	1.23291 ± 81.7	0.92146 ± 125.9	3.20352 ± 20.2	3.88717 ± 46.1	1.14568 ± 104.4	0.33875 ± 122.1	0.77912 ± 79.1
Active Antibody-Drug Conjugate (ADC)	0.1 ± 0.0	0.1 ± 0.00	0.1 ± 0.00	0.27671 ± 95.3	0.36894 ± 90.7	0.21835 ± 152.7	1.27047 ± 39.5	1.90678 ± 59.1	0.31524 ± 111.4	0.18096 ± 97.4	0.24389 ± 81.0
Unconjugated Tubulysin	0.0005 ± 0.0	0.0005 ± 0.0	0.0005 ± 0.0	0.0005 ± 0.0	0.0009 ± 127.6	0.0007 ± 66.6	0.0006 ± 64.7	0.00018 ± 104.0	0.0006 ± 80.7	0.0005 ± 0.0	0.0005 ± 40.8

No statistical analyses for this end point

Secondary: Area Under the Concentration-Time Curve from Time Zero to Time T (AUC(0-t))

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End point title

Area Under the Concentration-Time Curve from Time Zero to Time T (AUC(0-t)) ^[42]

End point description

Area under the concentration-time curve from time Zero to time T (AUC(0-t)) of BMS-986148 grouped by dose + dose regimen. Note: The geometric CV was not calculated. Arithmetic % CV is reported instead.

End point type

Secondary

End point timeframe

PK blood assessment include cycle 1-day 1

Notes
[42] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
Justification: Baseline period arm is reported within the subject analysis set

End point values	BMS-986148 0.1MG/KG Q3W	BMS-986148 0.2MG/KG Q3W	BMS-986148 0.4MG/KG Q3W	BMS-986148 0.8MG/KG Q3W	BMS-986148 1.2MG/KG Q3W Es	BMS-986148 1.6MG/KG Q3W	BMS-986148 0.4MG/KG QW	BMS-986148 0.6MG/KG QW	BMS-986148 0.8MG/KG Q3W+Nivolumab	BMS 1.2MG/KG Q3W Ex
Number of subjects analysed	2 ^[43]	2 ^[44]	3 ^[45]	8 ^[46]	8 ^[47]	10 ^[48]	8 ^[49]	4 ^[50]	11 ^[51]	49 ^[52]
Units: h*ug/mL
geometric mean (geometric coefficient of variation)
Total Antibody	152.6 ± 31.6	232.5 ± 17.5	129.6 ± 131.3	1979.5 ± 69.6	4285.7 ± 29.3	5399.8 ± 40.1	858.0 ± 22.9	1278.8 ± 35.1	1815.8 ± 43.4	3472.6 ± 47.1
Active Antibody-Drug Conjugate (ADC)	88.6 ± 48.7	70.7 ± 42.9	60.8 ± 136.2	1042.1 ± 68.6	2493.1 ± 25.1	3083.6 ± 32.3	565.4 ± 30.3	927.3 ± 38.7	1059.0 ± 44.8	1984.7 ± 45.7
Unconjugated Tubulysin	99999 ± 99999	99999 ± 99999	49.6 ± 99999	29.6 ± 42.8	197.0 ± 59.4	80.1 ± 73.4	9.3 ± 73.0	42.5 ± 84.3	25.5 ± 58.8	42.3 ± 80.4

Notes
[43] - Unconjugated Tubulysin = 0 participants analyzed
[44] - Unconjugated Tubulysin = 0 participants analyzed
[45] - Unconjugated Tubulysin = 1 participants analyzed
[46] - Unconjugated Tubulysin = 4 participants analyzed
[47] - Total antibody and ADC = 7 participants analyzed
[48] - Unconjugated Tubulysin = 9 participants analyzed
[49] - Unconjugated Tubulysin = 2 participants analyzed
[50] - Unconjugated Tubulysin = 2 participants analyzed
[51] - Unconjugated Tubulysin = 5 participants analyzed
[52] - Unconjugated Tubulysin = 45 participants analyzed

No statistical analyses for this end point

Secondary: Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])

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End point title

Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) ^[53]

End point description

Area under the concentration-time curve in one dosing interval (AUC[TAU]) of BMS-986148 grouped by dose + dose regimen Note: The geometric CV was not calculated. Arithmetic % CV is reported instead

End point type

Secondary

End point timeframe

PK blood assessment include cycle 1-day 1

Notes
[53] - 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: Baseline period arm is reported within the subject analysis set

End point values	BMS-986148 0.1MG/KG Q3W	BMS-986148 0.2MG/KG Q3W	BMS-986148 0.4MG/KG Q3W	BMS-986148 0.8MG/KG Q3W	BMS-986148 1.2MG/KG Q3W Es	BMS-986148 1.6MG/KG Q3W	BMS-986148 0.4MG/KG QW	BMS-986148 0.6MG/KG QW	BMS 1.2MG/KG Q3W Ex	BMS 0.8MG/KG Q3W+Nivolumab Es	BMS 0.8MG/KG Q3W+Nivolumab Ex
Number of subjects analysed	2 ^[54]	2 ^[55]	2 ^[56]	8 ^[57]	7 ^[58]	10 ^[59]	8 ^[60]	3 ^[61]	46 ^[62]	10 ^[63]	17 ^[64]
Units: h*ug/mL
geometric mean (geometric coefficient of variation)
Total Antibody	179.3 ± 34.8	265.7 ± 13.3	344.6 ± 98.5	2059.3 ± 68.7	4316.1 ± 28.8	5318.6 ± 36.9	858.0 ± 22.9	1533.5 ± 19.2	4159.4 ± 39.5	1839.0 ± 45.4	2689.9 ± 34.0
Active Antibody-Drug Conjugate (ADC)	109.0 ± 35.2	99999 ± 99999	371.6 ± 99999	1098.7 ± 67.5	2507.2 ± 24.7	3246.0 ± 36.6	565.4 ± 30.3	1063.9 ± 32.2	2271.7 ± 40.1	1094.9 ± 48.0	1478.1 ± 36.6
Unconjugated Tubulysin	99999 ± 99999	99999 ± 99999	99999 ± 99999	99999 ± 99999	197.0 ± 59.4	173.4 ± 48.2	9.3 ± 73.0	42.5 ± 84.3	148.9 ± 30.3	99999 ± 99999	102.4 ± 99999

Notes
[54] - Unconjugated Tubulysin = 0 participants analyzed
[55] - ADC and Unconjugated Tubulysin = 0 participants analyzed
[56] - ADC = 1 participants analyzed Unconjugated Tubulysin = 0 participants analyzed
[57] - Unconjugated Tubulysin = 0 participants analyzed
[58] - Unconjugated Tubulysin = 3 participants analyzed
[59] - Total Antibody = 8 participants analyzed Unconjugated Tubulysin = 2 participants analyzed
[60] - Unconjugated Tubulysin = 2 participants analyzed
[61] - Unconjugated Tubulysin = 2 participants analyzed
[62] - Unconjugated Tubulysin = 6 participants analyzed
[63] - Total antibody = 9 participants analyzed Unconjugated Tubulysin = 0 participants analyzed
[64] - Unconjugated Tubulysin = 1 participants analyzed

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

Best overall response is defined as the best response designation over the study as a whole, recorded between the dates of first dose until the last tumor assessment prior to subsequent therapy. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must also demonstrate an absolute increase of at least 5 mm. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study.

End point type

Secondary

End point timeframe

Up to 58 months

End point values	BMS-986148 Mesothelioma	BMS-986148+Nivolumab Mesothelioma	BMS-986148 Ovarian	BMS-986148+Nivolumab Ovarian	BMS-986148 Pancreatic	BMS-986148+Nivolumab Pancreatic	BMS-986148 NSCLC	BMS-986148+Nivolumab NSCLC	BMS-986148 Gastric	BMS-986148+Nivolumab Gastric
Number of subjects analysed	25	13	22	2	18	6	4	2	3	1
Units: Participants
Complete Response (CR)	0	0	0	0	0	0	0	0	0	0
Partial Response (PR)	1	3	2	0	0	0	0	0	0	0
Stable Disease (SD)	13	8	11	2	4	1	1	1	1	0
Progressive Disease (PD)	7	1	7	0	11	2	2	1	2	1

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

Objective response rate is defined as the total percentage of participants whose best overall response (BOR) is either a complete response or partial response divided by the total percentage of participants who are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric). Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.

End point type

Secondary

End point timeframe

Up to 58 months

End point values	BMS-986148 Mesothelioma	BMS-986148+Nivolumab Mesothelioma	BMS-986148 Ovarian	BMS-986148+Nivolumab Ovarian	BMS-986148 Pancreatic	BMS-986148+Nivolumab Pancreatic	BMS-986148 NSCLC	BMS-986148+Nivolumab NSCLC	BMS-986148 Gastric	BMS-986148+Nivolumab Gastric
Number of subjects analysed	25	13	22	29	18	6	4	2	3	1
Units: Percentage of participants
number (confidence interval 95%)	1 (0.1 to 20.4)	3 (3.0 to 53.8)	2 (1.1 to 29.2)	2 (0.8 to 22.8)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)	99999 (99999 to 99999)

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

Duration of response is defined as the time between the date of first response and the subsequent date of objectively documented disease progression or death, whichever occurs first. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).

End point type

Secondary

End point timeframe

Up to 58 months

End point values	BMS-986148 Mesothelioma	BMS-986148+Nivolumab Mesothelioma	BMS-986148 Ovarian	BMS-986148+Nivolumab Ovarian	BMS-986148 Pancreatic	BMS-986148+Nivolumab Pancreatic	BMS-986148 NSCLC	BMS-986148+Nivolumab NSCLC	BMS-986148 Gastric	BMS-986148+Nivolumab Gastric
Number of subjects analysed	25	13	22	0 ^[65]	0 ^[66]	6	4	0 ^[67]	0 ^[68]	0 ^[69]
Units: Months
median (full range (min-max))	29.7 (29.7 to 29.7)	8.97 (5.1 to 13.3)	99999 (3.0 to 99999)	( to )	( to )	99999 (99999 to 99999)	99999 (99999 to 99999)	( to )	( to )	( to )

Notes
[65] - 0 subjects analyzed
[66] - 0 subjects analyzed
[67] - 0 subjects analyzed
[68] - 0 subjects analyzed
[69] - 0 subjects analyzed

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

Progression Free Survival 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. Progression is defined with at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study and the sum must also demonstrate an absolute increase of at least 5 mm. Participants who did not progress nor died will be censored on the date of their last tumor assessment. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).

End point type

Secondary

End point timeframe

Up to 58 months

End point values	BMS-986148 Mesothelioma	BMS-986148+Nivolumab Mesothelioma	BMS-986148 Ovarian	BMS-986148+Nivolumab Ovarian	BMS-986148 Pancreatic	BMS-986148+Nivolumab Pancreatic	BMS-986148 NSCLC	BMS-986148+Nivolumab NSCLC	BMS-986148 Gastric	BMS-986148+Nivolumab Gastric
Number of subjects analysed	25	13	22	0 ^[70]	0 ^[71]	6	4	0 ^[72]	0 ^[73]	0 ^[74]
Units: Months
median (confidence interval 95%)	2.56 (1.41 to 4.01)	5.19 (2.56 to 12.06)	2.79 (1.28 to 4.17)	( to )	( to )	1.66 (1.22 to 2.14)	1.49 (1.15 to 5.65)	( to )	( to )	( to )

Notes
[70] - 0 subjects analyzed
[71] - 0 subjects analyzed
[72] - 0 subjects analyzed
[73] - 0 subjects analyzed
[74] - 0 subjects analyzed

No statistical analyses for this end point

Secondary: Progression Free Survival Rate (PFSR) at Week t

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End point title

Progression Free Survival Rate (PFSR) at Week t

End point description

Progression free survival rate is defined as the percentage of participants who remain progression free and surviving at ‘t’ weeks (t=4-12 months). The percentage will be calculated by the product-limit method (Kaplan-Meier estimate) which takes into account censored data. Participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung (NSCL), and Gastric).

End point type

Secondary

End point timeframe

Up to 58 months

End point values	BMS-986148 Mesothelioma	BMS-986148+Nivolumab Mesothelioma	BMS-986148 Ovarian	BMS-986148+Nivolumab Ovarian	BMS-986148 Pancreatic	BMS-986148+Nivolumab Pancreatic	BMS-986148 NSCLC	BMS-986148+Nivolumab NSCLC	BMS-986148 Gastric	BMS-986148+Nivolumab Gastric
Number of subjects analysed	25	13	22	0 ^[75]	0 ^[76]	0 ^[77]	0 ^[78]	0 ^[79]	0 ^[80]	0 ^[81]
Units: Percentage of participants
number (confidence interval 95%)
4 months	0.35 (0.15 to 0.54)	0.65 (0.37 to 0.93)	0.40 (0.18 to 0.62)	( to )	( to )	( to )	( to )	( to )	( to )	( to )
6 months	0.30 (0.11 to 0.49)	0.47 (0.17 to 0.76)	99999 (99999 to 99999)	( to )	( to )	( to )	( to )	( to )	( to )	( to )

Notes
[75] - 0 subjects analyzed
[76] - 0 subjects analyzed
[77] - 0 subjects analyzed
[78] - 0 subjects analyzed
[79] - 0 subjects analyzed
[80] - 0 subjects analyzed
[81] - 0 subjects analyzed

No statistical analyses for this end point

Secondary: Changes in QT Corrected by the Fridericia Formula (QTcF) from Baseline, at Selected Times

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End point title

Changes in QT Corrected by the Fridericia Formula (QTcF) from Baseline, at Selected Times ^[82]

End point description

Changes of participants in QT corrected by the fridericia formula (QTcF) Interval from baseline at <= 30 msec, >30 - <= 60 msec, and > 60 msec grouped by dose + dose regimen

End point type

Secondary

End point timeframe

Up to 58 months

Notes
[82] - 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: Baseline period arm is reported within the subject analysis set

End point values	BMS-986148 0.1MG/KG Q3W	BMS-986148 0.2MG/KG Q3W	BMS-986148 0.4MG/KG Q3W	BMS-986148 0.8MG/KG Q3W	BMS-986148 1.2MG/KG Q3W Es	BMS-986148 1.6MG/KG Q3W	BMS-986148 0.4MG/KG QW	BMS-986148 0.6MG/KG QW	BMS-986148 0.8MG/KG Q3W+Nivolumab	BMS 1.2MG/KG Q3W Ex
Number of subjects analysed	2	2	3	8	8	10	8	4	30	51
Units: Participants
<= 30 msec,	1	2	2	6	8	9	5	3	23	37
>30 - <= 60 msec	1	0	1	2	0	1	3	1	7	12
> 60 msec	0	0	0	0	0	0	0	0	0	2

No statistical analyses for this end point

Secondary: Incidence of Participants with Anti-Drug Antibody (ADA)

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End point title

Incidence of Participants with Anti-Drug Antibody (ADA) ^[83]

End point description

Incidence of participants with anti-drug antibody (ADA) status grouped by dose + dose regimen

End point type

Secondary

End point timeframe

Up to 58 months

Notes
[83] - 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: Baseline period arm is reported within the subject analysis set

End point values	BMS-986148 0.1MG/KG Q3W	BMS-986148 0.2MG/KG Q3W	BMS-986148 0.4MG/KG Q3W	BMS-986148 0.8MG/KG Q3W	BMS-986148 1.2MG/KG Q3W Es	BMS-986148 1.6MG/KG Q3W	BMS-986148 0.4MG/KG QW	BMS-986148 0.6MG/KG QW	BMS-986148 0.8MG/KG Q3W+Nivolumab
Number of subjects analysed	0 ^[84]	0 ^[85]	0 ^[86]	0 ^[87]	0 ^[88]	0 ^[89]	0 ^[90]	0 ^[91]	0 ^[92]
Units: Participants
ADA positive
ADA negative

Notes
[84] - 0 subjects analyzed
[85] - 0 subjects analyzed
[86] - 0 subjects analyzed
[87] - 0 subjects analyzed
[88] - 0 subjects analyzed
[89] - 0 subjects analyzed
[90] - 0 subjects analyzed
[91] - 0 subjects analyzed
[92] - 0 subjects analyzed

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

All adverse events were collected from the first dose up to 60 days (inclusive) after the last dose of BMS-986148

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

23.0

Reporting group title

BMS 0.2MG/KG Q3W

Reporting group description

Subjects were intravenously administered with monotherapy of 0.2 mg/kg BMS-986148 every 3 weeks.

Reporting group title

BMS 0.1MG/KG Q3W

Reporting group description

Subjects were intravenously administered with monotherapy of 0.1 milligrams per kilograms (mg/kg) BMS-986148 every 3 weeks.

Reporting group title

BMS 0.8MG/KG Q3W

Reporting group description

Subjects were intravenously administered with monotherapy of 0.8 mg/kg BMS-986148 every 3 weeks.

Reporting group title

BMS 0.4MG/KG Q3W

Reporting group description

Subjects were intravenously administered with monotherapy of 0.4 mg/kg BMS-986148 every 3 weeks.

Reporting group title

BMS 1.6MG/KG Q3W

Reporting group description

Subjects were intravenously administered with monotherapy of 1.6 mg/kg BMS-986148 every 3 weeks.

Reporting group title

BMS 0.4MG/KG QW

Reporting group description

Subjects were intravenously administered with monotherapy of 0.4 mg/kg BMS-986148 weekly for 3 weeks with one week off.

Reporting group title

BMS 1.2MG/KG Q3W

Reporting group description

Subjects were intravenously administered with monotherapy of 1.2 mg/kg BMS-986148 every 3 weeks.

Reporting group title

BMS 0.6MG/KG QW

Reporting group description

Subjects were intravenously administered with monotherapy of 0.6 mg/kg BMS-986148 weekly for 3 weeks with one week off.

Reporting group title

BMS 0.8MG/KG Q3W+N

Reporting group description

Subjects were intravenously administered with combination therapy of BMS-986148 and nivolumab. The starting dose of 0.8 mg/kg BMS-986148 to be combined with nivolumab at 360 mg every 3 weeks. Followed by escalation to 1.2 mg/kg of BMS-986148 in combination with nivolumab 360 mg every 3 weeks.

Serious adverse events	BMS 0.2MG/KG Q3W	BMS 0.1MG/KG Q3W	BMS 0.8MG/KG Q3W	BMS 0.4MG/KG Q3W	BMS 1.6MG/KG Q3W	BMS 0.4MG/KG QW	BMS 1.2MG/KG Q3W	BMS 0.6MG/KG QW	BMS 0.8MG/KG Q3W+N
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 2 (50.00%)	1 / 2 (50.00%)	6 / 8 (75.00%)	1 / 3 (33.33%)	4 / 10 (40.00%)	6 / 8 (75.00%)	34 / 59 (57.63%)	3 / 4 (75.00%)	22 / 30 (73.33%)
number of deaths (all causes)	2	1	5	3	7	7	38	4	22
number of deaths resulting from adverse events
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)	3 / 8 (37.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	2 / 8 (25.00%)	14 / 59 (23.73%)	2 / 4 (50.00%)	10 / 30 (33.33%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 3	0 / 0	0 / 0	0 / 2	0 / 14	0 / 2	0 / 10
deaths causally related to treatment / all	0 / 1	0 / 0	0 / 3	0 / 0	0 / 0	0 / 2	0 / 14	0 / 2	0 / 8
Neoplasm malignant
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Neoplasm progression
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 1	0 / 0
Tumour haemorrhage
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Vascular disorders
Venous thrombosis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
General disorders and administration site conditions
Chest pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infusion site extravasation
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Malaise
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Non-cardiac chest pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Performance status decreased
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pyrexia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
Dyspnoea
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 3	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Interstitial lung disease
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pleural effusion
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pleurisy
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pleuritic pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	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
Pneumonitis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
Pulmonary embolism
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	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
Investigations
Blood creatinine increased
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Myocardial necrosis marker increased
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Transaminases increased
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	2 / 30 (6.67%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
Subdural haematoma
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Toxicity to various agents
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	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
Atrial flutter
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac failure
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Cardio-respiratory arrest
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0
Pericardial effusion
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pericarditis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	2 / 59 (3.39%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Tachycardia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
Depressed level of consciousness
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
Neuralgia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 3	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Paraparesis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0
Syncope
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	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 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
Abdominal pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	2 / 10 (20.00%)	0 / 8 (0.00%)	3 / 59 (5.08%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 2	0 / 0	0 / 4	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 / 1	0 / 0
Ascites
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	4 / 59 (6.78%)	0 / 4 (0.00%)	3 / 30 (10.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 5	0 / 0	0 / 3
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Diarrhoea
subjects affected / exposed	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	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
Duodenal obstruction
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Dysphagia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal obstruction
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ileus
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Ileus paralytic
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Impaired gastric emptying
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal obstruction
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intestinal perforation
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Intra-abdominal haemorrhage
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nausea
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	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
Rectal haemorrhage
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	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 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	1 / 3 (33.33%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 2	0 / 1	0 / 0	0 / 0	0 / 1	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
Subileus
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Vomiting
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Abdominal wall haematoma
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pancreatitis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatobiliary disorders
Bile duct obstruction
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Bile duct stenosis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cholangitis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Drug-induced liver injury
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1	0 / 0	0 / 2	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hepatitis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyperbilirubinaemia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Immune-mediated hepatitis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Jaundice
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
Urinary tract obstruction
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	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 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Back pain
subjects affected / exposed	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 2	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
Muscular weakness
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal chest pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
Abdominal infection
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Lymphangitis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Peritonitis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pneumonia
subjects affected / exposed	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	2 / 59 (3.39%)	0 / 4 (0.00%)	4 / 30 (13.33%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 1	0 / 2	0 / 0	0 / 5
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Sepsis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0	0 / 0
deaths causally related to treatment / all	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 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hypoglycaemia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Hyponatraemia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (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
deaths causally related to treatment / all	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	BMS 0.2MG/KG Q3W	BMS 0.1MG/KG Q3W	BMS 0.8MG/KG Q3W	BMS 0.4MG/KG Q3W	BMS 1.6MG/KG Q3W	BMS 0.4MG/KG QW	BMS 1.2MG/KG Q3W	BMS 0.6MG/KG QW	BMS 0.8MG/KG Q3W+N
Total subjects affected by non serious adverse events
subjects affected / exposed	2 / 2 (100.00%)	1 / 2 (50.00%)	8 / 8 (100.00%)	3 / 3 (100.00%)	10 / 10 (100.00%)	8 / 8 (100.00%)	58 / 59 (98.31%)	4 / 4 (100.00%)	27 / 30 (90.00%)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	1	0	1	0	0
Vascular disorders
Hypertension
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	0 / 4 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	0	0	0	0	0	2	0	2
Systolic hypertension
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Flushing
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	0
Hypotension
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	2 / 10 (20.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	2	0	2	0	1	0	0
General disorders and administration site conditions
Asthenia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	2	0	0	0	0	1	0
Chest discomfort
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Chest pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	10 / 59 (16.95%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	0	0	12	0	3
Chills
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	3 / 30 (10.00%)
occurrences all number	0	0	0	0	1	0	0	0	4
Fatigue
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)	5 / 8 (62.50%)	1 / 3 (33.33%)	8 / 10 (80.00%)	3 / 8 (37.50%)	32 / 59 (54.24%)	3 / 4 (75.00%)	15 / 30 (50.00%)
occurrences all number	2	0	19	1	15	4	60	7	21
Influenza like illness
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	1 / 4 (25.00%)	2 / 30 (6.67%)
occurrences all number	0	0	0	0	2	0	3	1	2
Malaise
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	1 / 59 (1.69%)	2 / 4 (50.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	1	1	1	2	1
Non-cardiac chest pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)	1 / 10 (10.00%)	3 / 8 (37.50%)	5 / 59 (8.47%)	1 / 4 (25.00%)	5 / 30 (16.67%)
occurrences all number	0	0	0	1	1	6	7	1	7
Oedema peripheral
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	2 / 10 (20.00%)	0 / 8 (0.00%)	9 / 59 (15.25%)	0 / 4 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	0	1	0	2	0	11	0	4
Pyrexia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	3 / 10 (30.00%)	1 / 8 (12.50%)	14 / 59 (23.73%)	2 / 4 (50.00%)	3 / 30 (10.00%)
occurrences all number	0	0	0	0	3	1	25	4	5
Early satiety
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Mucosal inflammation
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	1	0	0	0	0
Pain
subjects affected / exposed	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0	1	0	3	0	0
Immune system disorders
Hypersensitivity
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Reproductive system and breast disorders
Testicular pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Pelvic pain
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	1	0	0	0	0	0	0	0	0
Respiratory, thoracic and mediastinal disorders
Cough
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	3 / 8 (37.50%)	1 / 3 (33.33%)	2 / 10 (20.00%)	0 / 8 (0.00%)	13 / 59 (22.03%)	0 / 4 (0.00%)	5 / 30 (16.67%)
occurrences all number	0	0	3	1	2	0	18	0	5
Dysphonia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	1 / 59 (1.69%)	1 / 4 (25.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	0	1	1	1	1
Dyspnoea
subjects affected / exposed	1 / 2 (50.00%)	1 / 2 (50.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	5 / 10 (50.00%)	1 / 8 (12.50%)	20 / 59 (33.90%)	1 / 4 (25.00%)	5 / 30 (16.67%)
occurrences all number	1	1	1	0	5	1	31	1	6
Dyspnoea exertional
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	2	0	0	2	0	0	0
Epistaxis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	3 / 59 (5.08%)	0 / 4 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	0	0	0	1	0	3	0	2
Oropharyngeal pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	1 / 4 (25.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	1	0	2	1	1
Pleural effusion
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	2 / 8 (25.00%)	4 / 59 (6.78%)	0 / 4 (0.00%)	3 / 30 (10.00%)
occurrences all number	0	0	0	0	0	2	4	0	3
Pleuritic pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	3 / 10 (30.00%)	2 / 8 (25.00%)	7 / 59 (11.86%)	1 / 4 (25.00%)	3 / 30 (10.00%)
occurrences all number	0	0	1	0	4	5	10	2	4
Productive cough
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	7 / 59 (11.86%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	0	1	9	0	1
Rales
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	0	0	3	0
Throat irritation
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	1 / 4 (25.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	0	0	0	1	1
Haemoptysis
subjects affected / exposed	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	1	0	0	0	0	1	0	0
Hiccups
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	2 / 10 (20.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	1	0	2	0	0	0	1
Hypoxia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	1	0	0	0	1
Nasal congestion
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	1	0	0	0	0	0
Psychiatric disorders
Abnormal dreams
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Anxiety
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	3 / 59 (5.08%)	1 / 4 (25.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	1	0	3	1	1
Confusional state
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	2 / 59 (3.39%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	1	2	0	0
Delirium
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	0	1	0
Hallucination, auditory
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Insomnia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	2 / 8 (25.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	4 / 59 (6.78%)	0 / 4 (0.00%)	6 / 30 (20.00%)
occurrences all number	0	0	2	0	0	1	4	0	6
Depression
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	4	0	0	0	0	0	0
Hallucination
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	1	0	0	0	0	0	1	0	0
Investigations
Alanine aminotransferase increased
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	2 / 8 (25.00%)	0 / 3 (0.00%)	6 / 10 (60.00%)	3 / 8 (37.50%)	33 / 59 (55.93%)	3 / 4 (75.00%)	10 / 30 (33.33%)
occurrences all number	0	0	2	0	10	5	94	12	24
Aspartate aminotransferase increased
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	3 / 8 (37.50%)	0 / 3 (0.00%)	5 / 10 (50.00%)	2 / 8 (25.00%)	35 / 59 (59.32%)	3 / 4 (75.00%)	12 / 30 (40.00%)
occurrences all number	0	0	3	0	12	2	111	7	31
Blood alkaline phosphatase increased
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	5 / 10 (50.00%)	2 / 8 (25.00%)	18 / 59 (30.51%)	2 / 4 (50.00%)	5 / 30 (16.67%)
occurrences all number	0	0	0	0	7	2	31	3	11
Blood bilirubin increased
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	2 / 10 (20.00%)	2 / 8 (25.00%)	8 / 59 (13.56%)	2 / 4 (50.00%)	2 / 30 (6.67%)
occurrences all number	1	0	1	0	5	2	15	2	5
Blood creatinine increased
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	1 / 4 (25.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	1	1	0	1	2
Electrocardiogram QT prolonged
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Gamma-glutamyltransferase increased
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	4 / 59 (6.78%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	1	1	7	0	0
Lymphocyte count decreased
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	1 / 59 (1.69%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	0	2	1	0	3
Platelet count decreased
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	3 / 59 (5.08%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	3	5	0	0
Weight decreased
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	3 / 8 (37.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	5 / 59 (8.47%)	0 / 4 (0.00%)	5 / 30 (16.67%)
occurrences all number	0	0	5	0	0	0	8	0	8
Blood sodium increased
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Liver function test increased
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	1	0	0	0	1
Injury, poisoning and procedural complications
Fall
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	1 / 59 (1.69%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	1	1	1	0	1
Head injury
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Cardiac disorders
Atrial fibrillation
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	1	2	0	0
Mitral valve incompetence
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Pericarditis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0
Sinus bradycardia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0
Tachycardia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	0	0	0	1	0	0	0	2
Nervous system disorders
Dizziness
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)	2 / 8 (25.00%)	0 / 3 (0.00%)	3 / 10 (30.00%)	0 / 8 (0.00%)	5 / 59 (8.47%)	1 / 4 (25.00%)	1 / 30 (3.33%)
occurrences all number	2	0	3	0	4	0	8	1	1
Dysarthria
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Dysgeusia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	6 / 59 (10.17%)	2 / 4 (50.00%)	4 / 30 (13.33%)
occurrences all number	0	0	0	0	0	1	6	2	7
Headache
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	3 / 10 (30.00%)	0 / 8 (0.00%)	6 / 59 (10.17%)	1 / 4 (25.00%)	4 / 30 (13.33%)
occurrences all number	0	0	1	0	3	0	8	2	4
Neuropathy peripheral
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	4 / 59 (6.78%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	0	9	1	0
Peripheral sensory neuropathy
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	3 / 59 (5.08%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	0	1	5	0	1
Horner's syndrome
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Seizure
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Somnolence
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	2	0	0	0	0	0	0	0	0
Blood and lymphatic system disorders
Anaemia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	2 / 8 (25.00%)	6 / 59 (10.17%)	1 / 4 (25.00%)	2 / 30 (6.67%)
occurrences all number	0	0	0	0	1	3	7	4	3
Lymphopenia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Thrombocytopenia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	3 / 59 (5.08%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	0	3	2	0
Eye disorders
Blepharitis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	0	2	1	0
Cataract
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	3 / 59 (5.08%)	0 / 4 (0.00%)	3 / 30 (10.00%)
occurrences all number	0	0	0	0	0	0	4	0	4
Dry eye
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	2 / 8 (25.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	5 / 59 (8.47%)	0 / 4 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	0	2	0	0	0	6	0	2
Strabismus
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Vision blurred
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	6 / 59 (10.17%)	0 / 4 (0.00%)	3 / 30 (10.00%)
occurrences all number	0	0	0	0	0	0	8	0	3
Vitreous floaters
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	0	1	0	0	1
Chalazion
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Eye pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Lacrimation increased
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	1	0	1	0	0
Narrow anterior chamber angle
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Swelling of eyelid
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	0
Visual impairment
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Gastrointestinal disorders
Abdominal distension
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)	3 / 8 (37.50%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	5 / 59 (8.47%)	0 / 4 (0.00%)	2 / 30 (6.67%)
occurrences all number	1	0	5	0	2	1	5	0	3
Abdominal pain
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)	3 / 8 (37.50%)	0 / 3 (0.00%)	3 / 10 (30.00%)	4 / 8 (50.00%)	15 / 59 (25.42%)	1 / 4 (25.00%)	5 / 30 (16.67%)
occurrences all number	1	0	4	0	4	6	28	1	9
Abdominal pain lower
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	0 / 4 (0.00%)	4 / 30 (13.33%)
occurrences all number	0	0	1	0	0	0	4	0	4
Abdominal pain upper
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	4 / 59 (6.78%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	2	1	4	0	1
Ascites
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	3 / 10 (30.00%)	0 / 8 (0.00%)	5 / 59 (8.47%)	0 / 4 (0.00%)	6 / 30 (20.00%)
occurrences all number	0	0	5	0	5	0	5	0	16
Breath odour
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Constipation
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	4 / 10 (40.00%)	3 / 8 (37.50%)	16 / 59 (27.12%)	1 / 4 (25.00%)	10 / 30 (33.33%)
occurrences all number	0	0	0	0	4	3	26	1	14
Diarrhoea
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)	3 / 8 (37.50%)	0 / 3 (0.00%)	8 / 10 (80.00%)	1 / 8 (12.50%)	13 / 59 (22.03%)	1 / 4 (25.00%)	5 / 30 (16.67%)
occurrences all number	1	0	4	0	11	2	21	2	7
Dry mouth
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	3 / 10 (30.00%)	1 / 8 (12.50%)	5 / 59 (8.47%)	0 / 4 (0.00%)	5 / 30 (16.67%)
occurrences all number	0	0	0	0	3	1	6	0	5
Dyspepsia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	3 / 8 (37.50%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	5 / 59 (8.47%)	1 / 4 (25.00%)	3 / 30 (10.00%)
occurrences all number	0	0	4	0	1	0	6	1	3
Dysphagia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	1 / 4 (25.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	1	1	0	1	1
Eructation
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	0	0	0	0	0	2	0	2
Flatulence
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	1	1	2	0	0
Gastrooesophageal reflux disease
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	3 / 59 (5.08%)	0 / 4 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	0	0	0	1	0	4	0	3
Haemorrhoids
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	0	1	0	0	0	1	0	2
Nausea
subjects affected / exposed	1 / 2 (50.00%)	1 / 2 (50.00%)	5 / 8 (62.50%)	3 / 3 (100.00%)	7 / 10 (70.00%)	3 / 8 (37.50%)	30 / 59 (50.85%)	1 / 4 (25.00%)	13 / 30 (43.33%)
occurrences all number	1	1	7	4	15	4	55	1	24
Rectal haemorrhage
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Stomatitis
subjects affected / exposed	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	3 / 10 (30.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	1	0	0	4	0	1	0	2
Swollen tongue
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	0	0	0
Vomiting
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)	4 / 8 (50.00%)	2 / 3 (66.67%)	4 / 10 (40.00%)	0 / 8 (0.00%)	17 / 59 (28.81%)	1 / 4 (25.00%)	9 / 30 (30.00%)
occurrences all number	2	0	4	2	7	0	35	1	11
Abdominal discomfort
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Impaired gastric emptying
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	0
Retching
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Umbilical hernia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	0	1	0	0
Hepatobiliary disorders
Hyperbilirubinaemia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	3	0	1	0	0
Skin and subcutaneous tissue disorders
Dry skin
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	3 / 30 (10.00%)
occurrences all number	0	0	1	0	1	0	1	0	3
Pruritus
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	0 / 4 (0.00%)	6 / 30 (20.00%)
occurrences all number	0	0	0	0	1	0	2	0	10
Rash
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	4 / 59 (6.78%)	1 / 4 (25.00%)	4 / 30 (13.33%)
occurrences all number	0	0	0	0	0	0	6	2	5
Rash papular
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	3 / 30 (10.00%)
occurrences all number	0	0	0	0	0	0	0	0	4
Skin odour abnormal
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	0	0	2	0
Night sweats
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)	2 / 10 (20.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	1	2	0	0	0	4
Rash macular
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	1	0	0	0	0	1
Renal and urinary disorders
Acute kidney injury
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	1 / 4 (25.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	1	0	1	1	1
Chromaturia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	1 / 59 (1.69%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	1	2	0
Nocturia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	1	1	0	0
Proteinuria
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	0	1	1	0
Urine odour abnormal
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	0	0	3	0
Urinary retention
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	1	0	1	0	0
Endocrine disorders
Hypothyroidism
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	0	0	0	0	0	1	0	2
Musculoskeletal and connective tissue disorders
Arthralgia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	0 / 4 (0.00%)	4 / 30 (13.33%)
occurrences all number	0	0	1	0	0	0	2	0	6
Back pain
subjects affected / exposed	1 / 2 (50.00%)	1 / 2 (50.00%)	2 / 8 (25.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	1 / 8 (12.50%)	10 / 59 (16.95%)	1 / 4 (25.00%)	2 / 30 (6.67%)
occurrences all number	1	1	3	0	2	1	11	1	2
Flank pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	2 / 8 (25.00%)	3 / 59 (5.08%)	1 / 4 (25.00%)	3 / 30 (10.00%)
occurrences all number	0	0	0	0	4	3	6	5	7
Muscle spasms
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)	3 / 10 (30.00%)	0 / 8 (0.00%)	5 / 59 (8.47%)	0 / 4 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	0	0	1	5	0	9	0	3
Muscular weakness
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	0 / 4 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	0	0	0	1	0	3	0	2
Musculoskeletal chest pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	4 / 59 (6.78%)	1 / 4 (25.00%)	4 / 30 (13.33%)
occurrences all number	0	0	1	0	1	0	4	1	8
Musculoskeletal pain
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	2 / 10 (20.00%)	1 / 8 (12.50%)	7 / 59 (11.86%)	2 / 4 (50.00%)	3 / 30 (10.00%)
occurrences all number	1	0	0	0	2	1	11	4	5
Myalgia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	3 / 59 (5.08%)	0 / 4 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	0	0	0	1	0	5	0	2
Pain in extremity
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	4 / 59 (6.78%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	0	4	1	0
Groin pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	1	0	2	0	0
Musculoskeletal discomfort
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Neck pain
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	3 / 59 (5.08%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	0	0	3	0	2
Infections and infestations
Nasopharyngitis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	0	2	1	0
Pneumonia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	1 / 8 (12.50%)	3 / 59 (5.08%)	0 / 4 (0.00%)	4 / 30 (13.33%)
occurrences all number	0	0	0	0	0	1	3	0	6
Upper respiratory tract infection
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	0 / 4 (0.00%)	4 / 30 (13.33%)
occurrences all number	0	0	0	0	0	0	2	0	4
Urinary tract infection
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	3 / 59 (5.08%)	1 / 4 (25.00%)	2 / 30 (6.67%)
occurrences all number	0	0	0	0	1	0	4	1	3
Conjunctivitis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Cystitis
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	1	0	0	0	0
Lower respiratory tract infection
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	0	0	0	0
Oral herpes
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	1	0	5	0	1
Respiratory tract infection
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	1	0	0	0	1	0	1
Metabolism and nutrition disorders
Decreased appetite
subjects affected / exposed	1 / 2 (50.00%)	0 / 2 (0.00%)	6 / 8 (75.00%)	1 / 3 (33.33%)	5 / 10 (50.00%)	2 / 8 (25.00%)	26 / 59 (44.07%)	2 / 4 (50.00%)	11 / 30 (36.67%)
occurrences all number	1	0	8	1	8	2	47	2	19
Dehydration
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	1 / 4 (25.00%)	1 / 30 (3.33%)
occurrences all number	0	0	1	0	1	0	2	2	1
Hyperglycaemia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	1 / 3 (33.33%)	0 / 10 (0.00%)	2 / 8 (25.00%)	1 / 59 (1.69%)	1 / 4 (25.00%)	2 / 30 (6.67%)
occurrences all number	0	0	2	3	0	3	1	1	2
Hyperuricaemia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Hypoalbuminaemia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	4 / 59 (6.78%)	0 / 4 (0.00%)	4 / 30 (13.33%)
occurrences all number	0	0	0	0	1	0	4	0	4
Hypokalaemia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	1 / 8 (12.50%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	6 / 59 (10.17%)	0 / 4 (0.00%)	0 / 30 (0.00%)
occurrences all number	0	0	1	0	0	0	6	0	0
Hypomagnesaemia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	3 / 8 (37.50%)	1 / 3 (33.33%)	0 / 10 (0.00%)	0 / 8 (0.00%)	4 / 59 (6.78%)	1 / 4 (25.00%)	1 / 30 (3.33%)
occurrences all number	0	0	4	1	0	0	4	1	1
Hyponatraemia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)	0 / 10 (0.00%)	0 / 8 (0.00%)	2 / 59 (3.39%)	0 / 4 (0.00%)	2 / 30 (6.67%)
occurrences all number	0	0	0	1	0	0	3	0	5
Hypophosphataemia
subjects affected / exposed	0 / 2 (0.00%)	1 / 2 (50.00%)	0 / 8 (0.00%)	1 / 3 (33.33%)	2 / 10 (20.00%)	0 / 8 (0.00%)	5 / 59 (8.47%)	1 / 4 (25.00%)	1 / 30 (3.33%)
occurrences all number	0	1	0	1	2	0	6	1	1
Increased appetite
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	0 / 10 (0.00%)	0 / 8 (0.00%)	0 / 59 (0.00%)	1 / 4 (25.00%)	0 / 30 (0.00%)
occurrences all number	0	0	0	0	0	0	0	1	0
Hypoglycaemia
subjects affected / exposed	0 / 2 (0.00%)	0 / 2 (0.00%)	0 / 8 (0.00%)	0 / 3 (0.00%)	1 / 10 (10.00%)	0 / 8 (0.00%)	1 / 59 (1.69%)	0 / 4 (0.00%)	1 / 30 (3.33%)
occurrences all number	0	0	0	0	1	0	1	0	2

More information

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Were there any global substantial amendments to the protocol? Yes

31 Jul 2015

Added exclusion criteria for troponin. Added additional guidance on the collection of triplicate ECGs.

02 Feb 2016

Added details for flat dosing, Added IHC scoring details for Part 2 of the study. Clarified eligibility criteria.

12 Apr 2016

Updated eligibility criteria

21 Jul 2016

Removed flat dosing option. Added BMS-986148 and Nivolumab combination therapy arm (Part 3).

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 Study of BMS 986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects with Select Advanced Solid Tumors

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Incidence of Participants with Adverse Events at Worst CTC Grade

Primary: Incidence of Participants with Adverse Events at Worst CTC Grade

Primary: Number of Participants with Laboratory Test Toxicity Grade Shifting from Baseline

Primary: Number of Participants with Laboratory Test Toxicity Grade Shifting from Baseline

Secondary: Maximum Observed Serum Concentration (Cmax)

Secondary: Maximum Observed Serum Concentration (Cmax)

Secondary: Time of Maximum Observed Serum Concentration (Tmax)

Secondary: Time of Maximum Observed Serum Concentration (Tmax)

Secondary: Concentration at the End of a Dosing Interval (Ctau)

Secondary: Concentration at the End of a Dosing Interval (Ctau)

Secondary: Trough Observed Serum Concentration (Ctrough)

Secondary: Trough Observed Serum Concentration (Ctrough)

Secondary: Area Under the Concentration-Time Curve from Time Zero to Time T (AUC(0-t))

Secondary: Area Under the Concentration-Time Curve from Time Zero to Time T (AUC(0-t))

Secondary: Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])

Secondary: Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU])

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) at Week t

Secondary: Progression Free Survival Rate (PFSR) at Week t

Secondary: Changes in QT Corrected by the Fridericia Formula (QTcF) from Baseline, at Selected Times

Secondary: Changes in QT Corrected by the Fridericia Formula (QTcF) from Baseline, at Selected Times

Secondary: Incidence of Participants with Anti-Drug Antibody (ADA)

Secondary: Incidence of Participants with Anti-Drug Antibody (ADA)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

More information

Clinical Trial Results:
A Phase I/IIa Study of BMS 986148, a Mesothelin Directed Antibody Drug Conjugate, in Subjects with Select Advanced Solid Tumors