Trial Outcomes & Findings for A Study of BMS-986148 in Patients With Select Advanced Solid Tumors (NCT NCT02341625)

NCT ID: NCT02341625

Last Updated: 2022-08-18

Results Overview

Number 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.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 126 participants
• Primary outcome timeframe: From first dose to up to 100 days post last dose (Up to 6 months)
• Results posted on: 2022-08-18

Participant Flow

Participant milestones

Measure	BMS-986148 0.1MG/KG Q3W Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W	BMS-986148 1.6MG/KG Q3W Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Ex 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	BMS-986148 0.4MG/KG QW Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab 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
Overall Study STARTED	2	2	3	8	8	10	51	8	4	30
Overall Study COMPLETED	0	0	0	0	0	0	0	0	0	0
Overall Study NOT COMPLETED	2	2	3	8	8	10	51	8	4	30

Reasons for withdrawal

Measure	BMS-986148 0.1MG/KG Q3W Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W	BMS-986148 1.6MG/KG Q3W Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Ex 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	BMS-986148 0.4MG/KG QW Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab 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
Overall Study Disease Progression	2	2	3	6	7	7	28	5	4	19
Overall Study Study Drug Toxicity	0	0	0	1	0	3	10	0	0	3
Overall Study Adverse Event Unrelated to Study Drug	0	0	0	0	0	0	2	1	0	2
Overall Study Participant Request to Discontinue Study Treatment	0	0	0	0	0	0	6	2	0	0
Overall Study Participant Withdrew Consent	0	0	0	1	0	0	0	0	0	0
Overall Study Completed Treatment as per Protocol	0	0	0	0	0	0	0	0	0	1
Overall Study Other Reasons	0	0	0	0	1	0	5	0	0	2
Overall Study Not Reported	0	0	0	0	0	0	0	0	0	3

Baseline Characteristics

A Study of BMS-986148 in Patients With Select Advanced Solid Tumors

Baseline characteristics by cohort

Measure	BMS-986148 0.1MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=3 Participants Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=8 Participants Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es n=8 Participants Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W	BMS-986148 1.6MG/KG Q3W n=10 Participants Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Ex n=51 Participants 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	BMS-986148 0.4MG/KG QW n=8 Participants Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=4 Participants Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS 0.8MG/KG + Nivolumab Q3W n=30 Participants 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	Total n=126 Participants Total of all reporting groups
Age, Continuous	59.5 Years STANDARD_DEVIATION 0.7 • n=5 Participants	70.5 Years STANDARD_DEVIATION 0.7 • n=7 Participants	65.3 Years STANDARD_DEVIATION 5.8 • n=5 Participants	63.9 Years STANDARD_DEVIATION 5.4 • n=4 Participants	63.4 Years STANDARD_DEVIATION 5.1 • n=21 Participants	59.0 Years STANDARD_DEVIATION 16.0 • n=8 Participants	61.5 Years STANDARD_DEVIATION 9.5 • n=8 Participants	66.3 Years STANDARD_DEVIATION 8.6 • n=24 Participants	64.5 Years STANDARD_DEVIATION 9.1 • n=42 Participants	61.6 Years STANDARD_DEVIATION 9.4 • n=42 Participants	62.2 Years STANDARD_DEVIATION 9.4 • n=42 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants	3 Participants n=4 Participants	3 Participants n=21 Participants	3 Participants n=8 Participants	31 Participants n=8 Participants	3 Participants n=24 Participants	2 Participants n=42 Participants	12 Participants n=42 Participants	59 Participants n=42 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	7 Participants n=8 Participants	20 Participants n=8 Participants	5 Participants n=24 Participants	2 Participants n=42 Participants	18 Participants n=42 Participants	67 Participants n=42 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	1 Participants n=42 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants	8 Participants n=4 Participants	8 Participants n=21 Participants	10 Participants n=8 Participants	46 Participants n=8 Participants	8 Participants n=24 Participants	3 Participants n=42 Participants	25 Participants n=42 Participants	114 Participants n=42 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	5 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	5 Participants n=42 Participants	11 Participants n=42 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	4 Participants n=42 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	2 Participants n=8 Participants	0 Participants n=24 Participants	1 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants	7 Participants n=21 Participants	9 Participants n=8 Participants	46 Participants n=8 Participants	8 Participants n=24 Participants	3 Participants n=42 Participants	30 Participants n=42 Participants	116 Participants n=42 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants	0 Participants n=24 Participants	0 Participants n=42 Participants	0 Participants n=42 Participants	3 Participants n=42 Participants

PRIMARY outcome

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

Population: All treated participants

Number 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.

Outcome measures

Measure	BMS-986148 0.1MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=3 Participants Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=8 Participants Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W n=10 Participants Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es n=59 Participants Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW n=8 Participants Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=4 Participants Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab n=30 Participants 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	BMS 0.8MG/KG Q3W+Nivolumab Es Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle	BMS 0.8MG/KG Q3W+Nivolumab Ex 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
Number of Participants With Adverse Events at Worst CTC Grade Adverse Events (AEs)	1 Participants	2 Participants	3 Participants	8 Participants	10 Participants	59 Participants	8 Participants	4 Participants	30 Participants	—	—
Number of Participants With Adverse Events at Worst CTC Grade Serious Adverse Events (SAEs)	1 Participants	1 Participants	1 Participants	5 Participants	4 Participants	32 Participants	6 Participants	3 Participants	21 Participants	—	—
Number of Participants With Adverse Events at Worst CTC Grade Deaths	1 Participants	2 Participants	3 Participants	5 Participants	7 Participants	38 Participants	7 Participants	4 Participants	22 Participants	—	—
Number of Participants With Adverse Events at Worst CTC Grade AEs Leading to Discontinuation	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	11 Participants	1 Participants	0 Participants	7 Participants	—	—

PRIMARY outcome

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

Population: All treated participants

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.

Outcome measures

Measure	BMS-986148 0.1MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=3 Participants Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=8 Participants Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W n=10 Participants Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es n=59 Participants Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW n=8 Participants Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=4 Participants Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab n=30 Participants 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	BMS 0.8MG/KG Q3W+Nivolumab Es Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle	BMS 0.8MG/KG Q3W+Nivolumab Ex 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
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Alanine Aminotransferase (ALT) increase from baseline	0 Participants	0 Participants	0 Participants	7 Participants	10 Participants	50 Participants	5 Participants	3 Participants	25 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Neutrophils decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Absolute Neutrophil increase from baseline	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	3 Participants	0 Participants	0 Participants	2 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Lymphocytes increase from baseline	1 Participants	2 Participants	1 Participants	3 Participants	6 Participants	27 Participants	6 Participants	3 Participants	19 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Hemoglobin increase from baseline	1 Participants	1 Participants	0 Participants	3 Participants	3 Participants	20 Participants	2 Participants	1 Participants	12 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Hemoglobin decrease from baseline	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Platelet Count increase from baseline	0 Participants	0 Participants	0 Participants	3 Participants	4 Participants	14 Participants	0 Participants	1 Participants	6 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Platelet Count decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Leukocytes increase from baseline	0 Participants	0 Participants	1 Participants	0 Participants	2 Participants	1 Participants	1 Participants	0 Participants	2 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Leukocytes decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	1 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Neutrophils increase from baseline	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	3 Participants	0 Participants	0 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Lymphocytes decrease from baseline	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Absolute Neutrophil decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Alkaline Phosphatase (ALP) increase from baseline	0 Participants	1 Participants	1 Participants	6 Participants	10 Participants	46 Participants	5 Participants	4 Participants	24 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Alkaline Phosphatase (ALP) decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Aspartate Aminotransferase (AST) increase from baseline	0 Participants	1 Participants	1 Participants	6 Participants	10 Participants	53 Participants	6 Participants	4 Participants	26 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Aspartate Aminotransferase (AST) decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Alanine Aminotransferase (ALT) decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Bilirubin increase from baseline	0 Participants	1 Participants	0 Participants	2 Participants	3 Participants	16 Participants	2 Participants	2 Participants	7 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Bilirubin decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Creatinine increase from baseline	0 Participants	0 Participants	1 Participants	2 Participants	2 Participants	7 Participants	1 Participants	3 Participants	5 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Creatinine decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Sodium increase from baseline	0 Participants	1 Participants	1 Participants	4 Participants	4 Participants	23 Participants	1 Participants	2 Participants	17 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Sodium decrease from baseline	1 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Potassium increase from baseline	1 Participants	0 Participants	0 Participants	3 Participants	5 Participants	24 Participants	1 Participants	2 Participants	9 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Potassium decrease from baseline	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Calcium Total increase from baseline	0 Participants	0 Participants	0 Participants	5 Participants	4 Participants	17 Participants	3 Participants	1 Participants	10 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Calcium Total decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Calcium Corrected increase from baseline	0 Participants	0 Participants	0 Participants	2 Participants	1 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Calcium Corrected decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Phosphorus increase from baseline	2 Participants	0 Participants	2 Participants	3 Participants	4 Participants	24 Participants	1 Participants	2 Participants	7 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Phosphorus decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Magnesium increase from baseline	0 Participants	1 Participants	1 Participants	2 Participants	4 Participants	22 Participants	1 Participants	2 Participants	5 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Magnesium decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	3 Participants	0 Participants	0 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Glucose Fasting Serum increase from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	6 Participants	0 Participants	1 Participants	5 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Glucose Fasting Serum decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Albumin increase from baseline	0 Participants	1 Participants	0 Participants	7 Participants	8 Participants	37 Participants	6 Participants	2 Participants	19 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Albumin decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Amylase increase from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Amylase decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Lipase increase from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Lipase decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Creatine Kinase increase from baseline	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	9 Participants	0 Participants	0 Participants	3 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Creatine Kinase decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	1 Participants	0 Participants	0 Participants	0 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Uric Acid increase from baseline	0 Participants	0 Participants	1 Participants	1 Participants	2 Participants	6 Participants	0 Participants	2 Participants	6 Participants	—	—
Number of Participants With Laboratory Test Toxicity Grade Shifting From Baseline Uric Acid decrease from baseline	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—	—

SECONDARY outcome

Timeframe: PK blood assessed on cycle 1, day 1

Population: All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data

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.

Outcome measures

Measure	BMS-986148 0.1MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=3 Participants Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=8 Participants Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W n=10 Participants Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es n=8 Participants Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW n=49 Participants Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=8 Participants Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab n=4 Participants 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	BMS 0.8MG/KG Q3W+Nivolumab Es n=11 Participants Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle	BMS 0.8MG/KG Q3W+Nivolumab Ex n=17 Participants 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
Maximum Observed Serum Concentration (Cmax) Active Antibody-Drug Conjugate (ADC)	2.0 ug/mL Geometric Coefficient of Variation 29.8	2.2 ug/mL Geometric Coefficient of Variation 8.2	2.6 ug/mL Geometric Coefficient of Variation 76.1	15.8 ug/mL Geometric Coefficient of Variation 46.4	40.0 ug/mL Geometric Coefficient of Variation 26.3	27.0 ug/mL Geometric Coefficient of Variation 18.6	27.5 ug/mL Geometric Coefficient of Variation 22.6	8.8 ug/mL Geometric Coefficient of Variation 20.3	13.6 ug/mL Geometric Coefficient of Variation 31.0	15.3 ug/mL Geometric Coefficient of Variation 27.6	17.8 ug/mL Geometric Coefficient of Variation 24.6
Maximum Observed Serum Concentration (Cmax) Unconjugated Tubulysin	—	—	0.5 ug/mL Geometric Coefficient of Variation NA Too few events to calculate arithmetic coefficient of variation	0.2 ug/mL Geometric Coefficient of Variation 17.1	0.4 ug/mL Geometric Coefficient of Variation 52.3	0.4 ug/mL Geometric Coefficient of Variation 70.9	0.3 ug/mL Geometric Coefficient of Variation 58.2	0.1 ug/mL Geometric Coefficient of Variation 36.0	0.4 ug/mL Geometric Coefficient of Variation 75.0	0.2 ug/mL Geometric Coefficient of Variation 42.5	0.2 ug/mL Geometric Coefficient of Variation 42.5
Maximum Observed Serum Concentration (Cmax) Total Antibody	2.3 ug/mL Geometric Coefficient of Variation 31.4	2.8 ug/mL Geometric Coefficient of Variation 7.6	3.3 ug/mL Geometric Coefficient of Variation 76.7	16.4 ug/mL Geometric Coefficient of Variation 47.2	39.8 ug/mL Geometric Coefficient of Variation 24.5	28.5 ug/mL Geometric Coefficient of Variation 14.0	28.3 ug/mL Geometric Coefficient of Variation 22.5	9.3 ug/mL Geometric Coefficient of Variation 21.3	14.5 ug/mL Geometric Coefficient of Variation 22.3	16.7 ug/mL Geometric Coefficient of Variation 19.7	18.8 ug/mL Geometric Coefficient of Variation 22.4

SECONDARY outcome

Timeframe: PK blood assessed on cycle 1, day 1

Population: All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data

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

Outcome measures

Measure	BMS-986148 0.1MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=3 Participants Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=8 Participants Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W n=10 Participants Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es n=8 Participants Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW n=49 Participants Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=8 Participants Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab n=4 Participants 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	BMS 0.8MG/KG Q3W+Nivolumab Es n=11 Participants Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle	BMS 0.8MG/KG Q3W+Nivolumab Ex n=17 Participants 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
Time of Maximum Observed Serum Concentration (Tmax) Total Antibody	2.2 Hours Interval 0.3 to 4.0	2.2 Hours Interval 0.3 to 4.1	3.9 Hours Interval 0.5 to 4.7	4.0 Hours Interval 0.2 to 4.8	3.9 Hours Interval 0.9 to 4.3	4.1 Hours Interval 1.1 to 4.1	4.0 Hours Interval 0.8 to 24.1	4.0 Hours Interval 0.6 to 4.1	3.8 Hours Interval 1.1 to 3.9	1.1 Hours Interval 0.6 to 24.1	4.0 Hours Interval 0.9 to 23.8
Time of Maximum Observed Serum Concentration (Tmax) Active Antibody-Drug Conjugate (ADC)	0.2 Hours Interval 0.1 to 0.3	2.2 Hours Interval 0.3 to 4.1	0.5 Hours Interval 0.1 to 3.9	2.5 Hours Interval 0.2 to 4.0	1.5 Hours Interval 0.8 to 4.3	3.8 Hours Interval 1.0 to 4.1	3.9 Hours Interval 0.8 to 4.7	4.0 Hours Interval 0.6 to 4.1	3.8 Hours Interval 1.1 to 3.9	1.0 Hours Interval 0.6 to 4.2	4.0 Hours Interval 0.9 to 4.0
Time of Maximum Observed Serum Concentration (Tmax) Unconjugated Tubulysin	—	—	25.5 Hours Interval 25.5 to 25.5	120.2 Hours Interval 71.8 to 169.7	167.3 Hours Interval 71.4 to 170.0	168.8 Hours Interval 48.0 to 335.5	166.1 Hours Interval 24.3 to 338.8	168.2 Hours Interval 166.9 to 169.4	166.7 Hours Interval 94.7 to 238.7	165.1 Hours Interval 48.0 to 170.9	166.5 Hours Interval 47.8 to 335.9

SECONDARY outcome

Timeframe: PK blood assessed on cycle 1, day 1

Population: All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data

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.

Outcome measures

Measure	BMS-986148 0.1MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=8 Participants Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W n=10 Participants Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es n=7 Participants Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW n=46 Participants Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=8 Participants Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab n=3 Participants 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	BMS 0.8MG/KG Q3W+Nivolumab Es n=10 Participants Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle	BMS 0.8MG/KG Q3W+Nivolumab Ex n=17 Participants 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
Concentration at the End of a Dosing Interval (Ctau) Total Antibody	0.0035 ug/mL Geometric Coefficient of Variation 112.0	0.0333 ug/mL Geometric Coefficient of Variation 115.7	0.8233 ug/mL Geometric Coefficient of Variation 131.8	0.4426 ug/mL Geometric Coefficient of Variation 106.1	1.4101 ug/mL Geometric Coefficient of Variation 101.8	1.0917 ug/mL Geometric Coefficient of Variation 91.9	1.1938 ug/mL Geometric Coefficient of Variation 98.7	3.2035 ug/mL Geometric Coefficient of Variation 20.2	3.8872 ug/mL Geometric Coefficient of Variation 46.1	0.2133 ug/mL Geometric Coefficient of Variation 114.0	0.7544 ug/mL Geometric Coefficient of Variation 83.5
Concentration at the End of a Dosing Interval (Ctau) Active Antibody-Drug Conjugate (ADC)	0.0633 ug/mL Geometric Coefficient of Variation 141.3	—	0.0058 ug/mL Geometric Coefficient of Variation NA Too few events to calculate arithmetic coefficient of variation	0.0309 ug/mL Geometric Coefficient of Variation 123.8	0.3049 ug/mL Geometric Coefficient of Variation 110.0	0.2121 ug/mL Geometric Coefficient of Variation 111.3	0.1558 ug/mL Geometric Coefficient of Variation 123.4	1.2705 ug/mL Geometric Coefficient of Variation 39.5	1.9068 ug/mL Geometric Coefficient of Variation 59.1	0.1119 ug/mL Geometric Coefficient of Variation 187.1	0.0797 ug/mL Geometric Coefficient of Variation 103.7
Concentration at the End of a Dosing Interval (Ctau) Unconjugated Tubulysin	—	—	—	—	0.1630 ug/mL Geometric Coefficient of Variation 0.9	0.2590 ug/mL Geometric Coefficient of Variation 77.1	0.1634 ug/mL Geometric Coefficient of Variation 48.2	0.1388 ug/mL Geometric Coefficient of Variation 36.0	0.3539 ug/mL Geometric Coefficient of Variation 75.0	—	0.1330 ug/mL Geometric Coefficient of Variation NA Too few events to calculate arithmetic coefficient of variation

SECONDARY outcome

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

Population: All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data

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.

Outcome measures

Measure	BMS-986148 0.1MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=3 Participants Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=7 Participants Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W n=6 Participants Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es n=8 Participants Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW n=39 Participants Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=8 Participants Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab n=3 Participants 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	BMS 0.8MG/KG Q3W+Nivolumab Es n=10 Participants Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle	BMS 0.8MG/KG Q3W+Nivolumab Ex n=13 Participants 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
Trough Observed Serum Concentration (Ctrough) Total Antibody	0.1 ug/mL Geometric Coefficient of Variation 0.0	0.1 ug/mL Geometric Coefficient of Variation 0.00	0.1 ug/mL Geometric Coefficient of Variation 0.00	0.79676 ug/mL Geometric Coefficient of Variation 92.4	0.92146 ug/mL Geometric Coefficient of Variation 125.9	1.23291 ug/mL Geometric Coefficient of Variation 81.7	1.14568 ug/mL Geometric Coefficient of Variation 104.4	3.20352 ug/mL Geometric Coefficient of Variation 20.2	3.88717 ug/mL Geometric Coefficient of Variation 46.1	0.33875 ug/mL Geometric Coefficient of Variation 122.1	0.77912 ug/mL Geometric Coefficient of Variation 79.1
Trough Observed Serum Concentration (Ctrough) Active Antibody-Drug Conjugate (ADC)	0.1 ug/mL Geometric Coefficient of Variation 0.0	0.1 ug/mL Geometric Coefficient of Variation 0.00	0.1 ug/mL Geometric Coefficient of Variation 0.00	0.27671 ug/mL Geometric Coefficient of Variation 95.3	0.21835 ug/mL Geometric Coefficient of Variation 152.7	0.36894 ug/mL Geometric Coefficient of Variation 90.7	0.31524 ug/mL Geometric Coefficient of Variation 111.4	1.27047 ug/mL Geometric Coefficient of Variation 39.5	1.90678 ug/mL Geometric Coefficient of Variation 59.1	0.18096 ug/mL Geometric Coefficient of Variation 97.4	0.24389 ug/mL Geometric Coefficient of Variation 81.0
Trough Observed Serum Concentration (Ctrough) Unconjugated Tubulysin	0.00005 ug/mL Geometric Coefficient of Variation 0.0	0.00005 ug/mL Geometric Coefficient of Variation 0.0	0.00005 ug/mL Geometric Coefficient of Variation 0.0	0.00005 ug/mL Geometric Coefficient of Variation 0.0	0.00007 ug/mL Geometric Coefficient of Variation 66.6	0.00009 ug/mL Geometric Coefficient of Variation 127.6	0.00006 ug/mL Geometric Coefficient of Variation 80.7	0.00006 ug/mL Geometric Coefficient of Variation 64.7	0.00018 ug/mL Geometric Coefficient of Variation 104.0	0.00005 ug/mL Geometric Coefficient of Variation 0.0	0.00005 ug/mL Geometric Coefficient of Variation 40.8

SECONDARY outcome

Timeframe: PK blood assessment include cycle 1-day 1

Population: All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data

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.

Outcome measures

Measure	BMS-986148 0.1MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=3 Participants Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=8 Participants Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W n=10 Participants Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es n=8 Participants Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW n=51 Participants Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=8 Participants Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab n=4 Participants 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	BMS 0.8MG/KG Q3W+Nivolumab Es n=11 Participants Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle	BMS 0.8MG/KG Q3W+Nivolumab Ex n=19 Participants 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
Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) Total Antibody	152.6 h*ug/mL Geometric Coefficient of Variation 31.6	232.5 h*ug/mL Geometric Coefficient of Variation 17.5	129.6 h*ug/mL Geometric Coefficient of Variation 131.3	1979.5 h*ug/mL Geometric Coefficient of Variation 69.6	5399.8 h*ug/mL Geometric Coefficient of Variation 40.1	4285.7 h*ug/mL Geometric Coefficient of Variation 29.3	3472.6 h*ug/mL Geometric Coefficient of Variation 47.1	858.0 h*ug/mL Geometric Coefficient of Variation 22.9	1278.8 h*ug/mL Geometric Coefficient of Variation 35.1	1815.8 h*ug/mL Geometric Coefficient of Variation 43.4	2611.3 h*ug/mL Geometric Coefficient of Variation 33.5
Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) Active Antibody-Drug Conjugate (ADC)	88.6 h*ug/mL Geometric Coefficient of Variation 48.7	70.7 h*ug/mL Geometric Coefficient of Variation 42.9	60.8 h*ug/mL Geometric Coefficient of Variation 136.2	1042.1 h*ug/mL Geometric Coefficient of Variation 68.6	3083.6 h*ug/mL Geometric Coefficient of Variation 32.3	2493.1 h*ug/mL Geometric Coefficient of Variation 25.1	1984.7 h*ug/mL Geometric Coefficient of Variation 45.7	565.4 h*ug/mL Geometric Coefficient of Variation 30.3	927.3 h*ug/mL Geometric Coefficient of Variation 38.7	1059.0 h*ug/mL Geometric Coefficient of Variation 44.8	1447.5 h*ug/mL Geometric Coefficient of Variation 36.2
Area Under the Concentration-Time Curve From Time Zero to Time T (AUC(0-t)) Unconjugated Tubulysin	—	—	49.6 h*ug/mL Geometric Coefficient of Variation NA Too few events to calculate arithmetic coefficient of variation	29.6 h*ug/mL Geometric Coefficient of Variation 42.8	80.1 h*ug/mL Geometric Coefficient of Variation 73.4	197.0 h*ug/mL Geometric Coefficient of Variation 59.4	42.3 h*ug/mL Geometric Coefficient of Variation 80.4	9.3 h*ug/mL Geometric Coefficient of Variation 73.0	42.5 h*ug/mL Geometric Coefficient of Variation 84.3	25.5 h*ug/mL Geometric Coefficient of Variation 58.8	17.7 h*ug/mL Geometric Coefficient of Variation 110.3

SECONDARY outcome

Timeframe: PK blood assessment include cycle 1-day 1

Population: All participants who received at least one dose of BMS-986148 and have evaluable serum concentration data

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

Outcome measures

Measure	BMS-986148 0.1MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=8 Participants Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W n=10 Participants Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es n=7 Participants Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW n=46 Participants Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=8 Participants Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab n=3 Participants 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	BMS 0.8MG/KG Q3W+Nivolumab Es n=10 Participants Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle	BMS 0.8MG/KG Q3W+Nivolumab Ex n=17 Participants 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
Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) Total Antibody	179.3 h*ug/mL Geometric Coefficient of Variation 34.8	265.7 h*ug/mL Geometric Coefficient of Variation 13.3	344.6 h*ug/mL Geometric Coefficient of Variation 98.5	2059.3 h*ug/mL Geometric Coefficient of Variation 68.7	5318.6 h*ug/mL Geometric Coefficient of Variation 36.9	4316.1 h*ug/mL Geometric Coefficient of Variation 28.8	4159.4 h*ug/mL Geometric Coefficient of Variation 39.5	858.0 h*ug/mL Geometric Coefficient of Variation 22.9	1533.5 h*ug/mL Geometric Coefficient of Variation 19.2	1839.0 h*ug/mL Geometric Coefficient of Variation 45.4	2689.9 h*ug/mL Geometric Coefficient of Variation 34.0
Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) Active Antibody-Drug Conjugate (ADC)	109.0 h*ug/mL Geometric Coefficient of Variation 35.2	—	371.6 h*ug/mL Geometric Coefficient of Variation NA Too few events to calculate arithmetic coefficient of variation	1098.7 h*ug/mL Geometric Coefficient of Variation 67.5	3246.0 h*ug/mL Geometric Coefficient of Variation 36.6	2507.2 h*ug/mL Geometric Coefficient of Variation 24.7	2271.7 h*ug/mL Geometric Coefficient of Variation 40.1	565.4 h*ug/mL Geometric Coefficient of Variation 30.3	1063.9 h*ug/mL Geometric Coefficient of Variation 32.2	1094.9 h*ug/mL Geometric Coefficient of Variation 48.0	1478.1 h*ug/mL Geometric Coefficient of Variation 36.6
Area Under the Concentration-Time Curve in One Dosing Interval (AUC[TAU]) Unconjugated Tubulysin	—	—	—	—	173.4 h*ug/mL Geometric Coefficient of Variation 48.2	197.0 h*ug/mL Geometric Coefficient of Variation 59.4	148.9 h*ug/mL Geometric Coefficient of Variation 30.3	9.3 h*ug/mL Geometric Coefficient of Variation 73.0	42.5 h*ug/mL Geometric Coefficient of Variation 84.3	—	102.4 h*ug/mL Geometric Coefficient of Variation NA Too few events to calculate arithmetic coefficient of variation

SECONDARY outcome

Timeframe: Up to 58 months

Population: Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric)

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.

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.

Outcome measures

Measure	BMS-986148 0.1MG/KG Q3W n=25 Participants Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=13 Participants Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=22 Participants Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W n=18 Participants Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es n=6 Participants Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW n=4 Participants Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=2 Participants Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab n=3 Participants 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	BMS 0.8MG/KG Q3W+Nivolumab Es n=1 Participants Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle	BMS 0.8MG/KG Q3W+Nivolumab Ex 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
Best Overall Response (BOR) Complete Response (CR)	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Best Overall Response (BOR) Partial Response (PR)	1 Participants	3 Participants	2 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	—
Best Overall Response (BOR) Stable Disease (SD)	13 Participants	8 Participants	11 Participants	2 Participants	4 Participants	1 Participants	1 Participants	1 Participants	1 Participants	0 Participants	—
Best Overall Response (BOR) Progressive Disease (PD)	7 Participants	1 Participants	7 Participants	0 Participants	11 Participants	2 Participants	2 Participants	1 Participants	2 Participants	1 Participants	—

SECONDARY outcome

Timeframe: Up to 58 months

Population: Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric)

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.

Outcome measures

Measure	BMS-986148 0.1MG/KG Q3W n=25 Participants Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=13 Participants Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=22 Participants Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W n=18 Participants Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es n=6 Participants Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW n=4 Participants Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=2 Participants Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab n=3 Participants 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	BMS 0.8MG/KG Q3W+Nivolumab Es n=1 Participants Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle	BMS 0.8MG/KG Q3W+Nivolumab Ex 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
Objective Response Rate (ORR)	4.0 Percentage of participants Interval 0.1 to 20.4	23.1 Percentage of participants Interval 5.0 to 53.8	9.1 Percentage of participants Interval 1.1 to 29.2	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	0 Percentage of participants Interval 0.0 to 0.0	—

SECONDARY outcome

Timeframe: Up to 58 months

Population: Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All response evaluable participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric).

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).

Outcome measures

Measure	BMS-986148 0.1MG/KG Q3W n=1 Participants Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=3 Participants Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab 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	BMS 0.8MG/KG Q3W+Nivolumab Es Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle	BMS 0.8MG/KG Q3W+Nivolumab Ex 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
Duration of Response (DoR)	29.7 Months Interval 29.7 to 29.7	8.97 Months Interval 5.1 to 13.3	NA Months Interval 3.0 to 20.0 Median not reached due to insufficient number of events	—	—	—	—	—	—	—	—

SECONDARY outcome

Timeframe: Up to 58 months

Population: Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric).

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).

Outcome measures

Measure	BMS-986148 0.1MG/KG Q3W n=25 Participants Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=13 Participants Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=22 Participants Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W n=7 Participants Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es n=11 Participants Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW n=6 Participants Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=4 Participants Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab n=2 Participants 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	BMS 0.8MG/KG Q3W+Nivolumab Es n=3 Participants Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle	BMS 0.8MG/KG Q3W+Nivolumab Ex n=1 Participants 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
Progression Free Survival (PFS)	2.56 Months Interval 1.41 to 4.01	5.19 Months Interval 2.56 to 12.06	2.79 Months Interval 1.28 to 4.17	NA Months Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	1.64 Months Interval 1.45 to 1.71	NA Months Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	1.66 Months Interval 1.22 to 2.14	1.49 Months Interval 1.15 to 5.65	NA Months Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Months Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Months Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)

SECONDARY outcome

Timeframe: Total PFS assessed between 4 and 12 months, PFSR at months 4 and 6 to be reported

Population: Per-protocol, data for this Outcome Measure was collected by disease irrespective of dose. All treated participants are grouped by cohorts (Mesothelioma, Pancreatic, Ovarian, Non-smell Cell Lung Cancer (NSCLC), and Gastric).

Progression free survival rate is defined as the proportion of participants who remain progression free and surviving at 't' weeks (t=4-12 months). The proportion 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).

Outcome measures

Measure	BMS-986148 0.1MG/KG Q3W n=25 Participants Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=13 Participants Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=22 Participants Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W n=7 Participants Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es n=11 Participants Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW n=6 Participants Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=4 Participants Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab n=2 Participants 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	BMS 0.8MG/KG Q3W+Nivolumab Es n=3 Participants Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle	BMS 0.8MG/KG Q3W+Nivolumab Ex n=1 Participants 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
Progression Free Survival Rate (PFSR) at Week t 6 months	0.30 Proportion of participants Interval 0.11 to 0.49	0.47 Proportion of participants Interval 0.17 to 0.76	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)
Progression Free Survival Rate (PFSR) at Week t 4 months	0.35 Proportion of participants Interval 0.15 to 0.54	0.65 Proportion of participants Interval 0.37 to 0.93	0.40 Proportion of participants Interval 0.18 to 0.62	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)	NA Proportion of participants Median, Lower Limit and Upper Limit are NA for Kaplan-Meier estimate because no observations were available for calculation of estimate (or confidence of estimate)

SECONDARY outcome

Timeframe: Up to 58 months

Population: All treated participants

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

Outcome measures

Measure	BMS-986148 0.1MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=2 Participants Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=3 Participants Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=8 Participants Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W n=10 Participants Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W Es n=8 Participants Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW n=51 Participants Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=8 Participants Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab n=4 Participants 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	BMS 0.8MG/KG Q3W+Nivolumab Es n=30 Participants Part 3A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W + Nivolumab 360 mg Q3W in a 21-day cycle	BMS 0.8MG/KG Q3W+Nivolumab Ex 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
Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times <= 30 msec,	1 Participants	2 Participants	2 Participants	6 Participants	9 Participants	8 Participants	37 Participants	5 Participants	3 Participants	23 Participants	—
Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times >30 - <= 60 msec	1 Participants	0 Participants	1 Participants	2 Participants	1 Participants	0 Participants	12 Participants	3 Participants	1 Participants	7 Participants	—
Changes in QT Corrected by the Fridericia Formula (QTcF) From Baseline, at Selected Times > 60 msec	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	2 Participants	0 Participants	0 Participants	0 Participants	—

SECONDARY outcome

Timeframe: Up to 58 months

Population: All ADA evaluable participants

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

Data was not collected for this outcome measure.

Outcome measures

Outcome data not reported

Adverse Events

BMS-986148 0.1MG/KG Q3W

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

BMS-986148 0.2MG/KG Q3W

Serious events: 1 serious events

Other events: 2 other events

Deaths: 2 deaths

BMS-986148 0.4MG/KG Q3W

Serious events: 1 serious events

Other events: 3 other events

Deaths: 3 deaths

BMS-986148 0.8MG/KG Q3W

Serious events: 5 serious events

Other events: 8 other events

Deaths: 5 deaths

BMS-986148 1.6MG/KG Q3W

Serious events: 4 serious events

Other events: 10 other events

Deaths: 7 deaths

BMS-986148 1.2MG/KG Q3W

Serious events: 32 serious events

Other events: 57 other events

Deaths: 38 deaths

BMS-986148 0.4MG/KG QW

Serious events: 6 serious events

Other events: 8 other events

Deaths: 7 deaths

BMS-986148 0.6MG/KG QW

Serious events: 3 serious events

Other events: 4 other events

Deaths: 4 deaths

BMS-986148 0.8MG/KG Q3W+Nivolumab

Serious events: 21 serious events

Other events: 27 other events

Deaths: 22 deaths

Serious adverse events

Measure	BMS-986148 0.1MG/KG Q3W n=2 participants at risk Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=2 participants at risk Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=3 participants at risk Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=8 participants at risk Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W n=10 participants at risk Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W n=59 participants at risk Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW n=8 participants at risk Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=4 participants at risk Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab n=30 participants at risk 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
General disorders Chest pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Infusion site extravasation	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Malaise	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Non-cardiac chest pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Performance status decreased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Pyrexia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Hepatobiliary disorders Bile duct obstruction	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Cardiac disorders Atrial fibrillation	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Cardiac disorders Atrial flutter	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Cardiac disorders Cardiac failure	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Cardiac disorders Cardio-respiratory arrest	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Cardiac disorders Pericardial effusion	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Cardiac disorders Pericarditis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Cardiac disorders Tachycardia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	20.0% 2/10 • From first dose to 100 days post last dose (Up to 6 months)	5.1% 3/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Ascites	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	5.1% 3/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 3/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Diarrhoea	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Hepatobiliary disorders Bile duct stenosis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Hepatobiliary disorders Cholangitis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Duodenal obstruction	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Dysphagia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Gastrointestinal obstruction	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Ileus	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Ileus paralytic	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Intestinal obstruction	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Intestinal perforation	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Intra-abdominal haemorrhage	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Nausea	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	33.3% 1/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Subileus	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Vomiting	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Hepatobiliary disorders Drug-induced liver injury	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Hepatobiliary disorders Hepatitis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Hepatobiliary disorders Immune-mediated hepatitis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Hepatobiliary disorders Jaundice	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Infections and infestations Abdominal infection	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Infections and infestations Lymphangitis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Infections and infestations Peritonitis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Infections and infestations Pneumonia	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	13.3% 4/30 • From first dose to 100 days post last dose (Up to 6 months)
Infections and infestations Sepsis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Injury, poisoning and procedural complications Subdural haematoma	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Injury, poisoning and procedural complications Toxicity to various agents	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Investigations Blood creatinine increased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Investigations Myocardial necrosis marker increased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Investigations Transaminases increased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Back pain	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	22.0% 13/59 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 2/8 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 2/4 • From first dose to 100 days post last dose (Up to 6 months)	26.7% 8/30 • From first dose to 100 days post last dose (Up to 6 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm malignant	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Neoplasm progression	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Nervous system disorders Depressed level of consciousness	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Nervous system disorders Neuralgia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Nervous system disorders Paraparesis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Nervous system disorders Syncope	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Renal and urinary disorders Urinary tract obstruction	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Pleurisy	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Vascular disorders Venous thrombosis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)

Other adverse events

Measure	BMS-986148 0.1MG/KG Q3W n=2 participants at risk Part 1A Dose Escalation: BMS-986148 0.1 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.2MG/KG Q3W n=2 participants at risk Part 1A Dose Escalation: BMS-986148 0.2 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.4MG/KG Q3W n=3 participants at risk Part 1A Dose Escalation: BMS-986148 0.4 mg/kg IV Q3W in a 21-day cycle	BMS-986148 0.8MG/KG Q3W n=8 participants at risk Part 1A Dose Escalation: BMS-986148 0.8 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.6MG/KG Q3W n=10 participants at risk Part 1A Dose Escalation: BMS-986148 1.6 mg/kg IV Q3W in a 21-day cycle	BMS-986148 1.2MG/KG Q3W n=59 participants at risk Part 1A Dose Escalation BMS-986148 1.2 mg/kg IV Q3W 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	BMS-986148 0.4MG/KG QW n=8 participants at risk Part 1B Dose Escalation: BMS-986148 0.4 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.6MG/KG QW n=4 participants at risk Part 1B Dose Escalation: BMS-986148 0.6 mg/kg IV QW for 3 weeks and 1 week off in a 28-day cycle	BMS-986148 0.8MG/KG Q3W+Nivolumab n=30 participants at risk 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
Investigations Aspartate aminotransferase increased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	37.5% 3/8 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 5/10 • From first dose to 100 days post last dose (Up to 6 months)	59.3% 35/59 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 2/8 • From first dose to 100 days post last dose (Up to 6 months)	75.0% 3/4 • From first dose to 100 days post last dose (Up to 6 months)	40.0% 12/30 • From first dose to 100 days post last dose (Up to 6 months)
Investigations Blood alkaline phosphatase increased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 5/10 • From first dose to 100 days post last dose (Up to 6 months)	30.5% 18/59 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 2/8 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 2/4 • From first dose to 100 days post last dose (Up to 6 months)	16.7% 5/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	6.8% 4/59 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 2/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 3/30 • From first dose to 100 days post last dose (Up to 6 months)
Blood and lymphatic system disorders Anaemia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	8.5% 5/59 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 2/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Blood and lymphatic system disorders Lymphopenia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Cardiac disorders Atrial fibrillation	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Cardiac disorders Mitral valve incompetence	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Cardiac disorders Pericarditis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Cardiac disorders Sinus bradycardia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Cardiac disorders Tachycardia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Endocrine disorders Hypothyroidism	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Eye disorders Blepharitis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Eye disorders Cataract	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	5.1% 3/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 3/30 • From first dose to 100 days post last dose (Up to 6 months)
Eye disorders Chalazion	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Eye disorders Dry eye	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 2/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	8.5% 5/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Eye disorders Eye pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Eye disorders Lacrimation increased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Eye disorders Narrow anterior chamber angle	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Eye disorders Strabismus	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Eye disorders Swelling of eyelid	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Eye disorders Vision blurred	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	10.2% 6/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 3/30 • From first dose to 100 days post last dose (Up to 6 months)
Eye disorders Visual impairment	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Eye disorders Vitreous floaters	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Abdominal discomfort	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Abdominal distension	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	37.5% 3/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	6.8% 4/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Abdominal pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	37.5% 3/8 • From first dose to 100 days post last dose (Up to 6 months)	30.0% 3/10 • From first dose to 100 days post last dose (Up to 6 months)	25.4% 15/59 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 4/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	16.7% 5/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Abdominal pain lower	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	13.3% 4/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Abdominal pain upper	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	6.8% 4/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Ascites	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	30.0% 3/10 • From first dose to 100 days post last dose (Up to 6 months)	8.5% 5/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	20.0% 6/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Breath odour	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Constipation	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	40.0% 4/10 • From first dose to 100 days post last dose (Up to 6 months)	27.1% 16/59 • From first dose to 100 days post last dose (Up to 6 months)	37.5% 3/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	33.3% 10/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Diarrhoea	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	37.5% 3/8 • From first dose to 100 days post last dose (Up to 6 months)	80.0% 8/10 • From first dose to 100 days post last dose (Up to 6 months)	22.0% 13/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	16.7% 5/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Dry mouth	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	30.0% 3/10 • From first dose to 100 days post last dose (Up to 6 months)	8.5% 5/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	16.7% 5/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Dyspepsia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	37.5% 3/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	8.5% 5/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 3/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Dysphagia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Eructation	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Flatulence	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Gastrooesophageal reflux disease	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	5.1% 3/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Haemorrhoids	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Impaired gastric emptying	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Nausea	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	100.0% 3/3 • From first dose to 100 days post last dose (Up to 6 months)	62.5% 5/8 • From first dose to 100 days post last dose (Up to 6 months)	70.0% 7/10 • From first dose to 100 days post last dose (Up to 6 months)	50.8% 30/59 • From first dose to 100 days post last dose (Up to 6 months)	37.5% 3/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	43.3% 13/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Rectal haemorrhage	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Retching	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Stomatitis	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	30.0% 3/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Swollen tongue	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Umbilical hernia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Gastrointestinal disorders Vomiting	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	66.7% 2/3 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 4/8 • From first dose to 100 days post last dose (Up to 6 months)	40.0% 4/10 • From first dose to 100 days post last dose (Up to 6 months)	28.8% 17/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	30.0% 9/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Asthenia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Chest discomfort	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Chest pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	16.9% 10/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Chills	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 3/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Early satiety	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Fatigue	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	33.3% 1/3 • From first dose to 100 days post last dose (Up to 6 months)	62.5% 5/8 • From first dose to 100 days post last dose (Up to 6 months)	80.0% 8/10 • From first dose to 100 days post last dose (Up to 6 months)	54.2% 32/59 • From first dose to 100 days post last dose (Up to 6 months)	37.5% 3/8 • From first dose to 100 days post last dose (Up to 6 months)	75.0% 3/4 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 15/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Influenza like illness	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Malaise	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 2/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Mucosal inflammation	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Non-cardiac chest pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	33.3% 1/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	8.5% 5/59 • From first dose to 100 days post last dose (Up to 6 months)	37.5% 3/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	16.7% 5/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Oedema peripheral	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	20.0% 2/10 • From first dose to 100 days post last dose (Up to 6 months)	13.6% 8/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Pain	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
General disorders Pyrexia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	30.0% 3/10 • From first dose to 100 days post last dose (Up to 6 months)	23.7% 14/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 2/4 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 3/30 • From first dose to 100 days post last dose (Up to 6 months)
Hepatobiliary disorders Hyperbilirubinaemia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Immune system disorders Hypersensitivity	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Infections and infestations Conjunctivitis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Infections and infestations Cystitis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Infections and infestations Lower respiratory tract infection	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Infections and infestations Nasopharyngitis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Infections and infestations Oral herpes	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Infections and infestations Pneumonia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	5.1% 3/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	13.3% 4/30 • From first dose to 100 days post last dose (Up to 6 months)
Infections and infestations Respiratory tract infection	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Infections and infestations Upper respiratory tract infection	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	13.3% 4/30 • From first dose to 100 days post last dose (Up to 6 months)
Infections and infestations Urinary tract infection	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	5.1% 3/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Injury, poisoning and procedural complications Fall	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Injury, poisoning and procedural complications Head injury	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Investigations Alanine aminotransferase increased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 2/8 • From first dose to 100 days post last dose (Up to 6 months)	60.0% 6/10 • From first dose to 100 days post last dose (Up to 6 months)	55.9% 33/59 • From first dose to 100 days post last dose (Up to 6 months)	37.5% 3/8 • From first dose to 100 days post last dose (Up to 6 months)	75.0% 3/4 • From first dose to 100 days post last dose (Up to 6 months)	33.3% 10/30 • From first dose to 100 days post last dose (Up to 6 months)
Investigations Blood bilirubin increased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	20.0% 2/10 • From first dose to 100 days post last dose (Up to 6 months)	13.6% 8/59 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 2/8 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 2/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Investigations Blood creatinine increased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Investigations Blood sodium increased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Investigations Electrocardiogram QT prolonged	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Investigations Gamma-glutamyltransferase increased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	6.8% 4/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Investigations Liver function test increased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Investigations Lymphocyte count decreased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Investigations Platelet count decreased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	5.1% 3/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Investigations Weight decreased	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	37.5% 3/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	6.8% 4/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	16.7% 5/30 • From first dose to 100 days post last dose (Up to 6 months)
Metabolism and nutrition disorders Decreased appetite	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	33.3% 1/3 • From first dose to 100 days post last dose (Up to 6 months)	75.0% 6/8 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 5/10 • From first dose to 100 days post last dose (Up to 6 months)	44.1% 26/59 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 2/8 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 2/4 • From first dose to 100 days post last dose (Up to 6 months)	36.7% 11/30 • From first dose to 100 days post last dose (Up to 6 months)
Metabolism and nutrition disorders Dehydration	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	33.3% 1/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 2/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	6.8% 4/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	13.3% 4/30 • From first dose to 100 days post last dose (Up to 6 months)
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	8.5% 5/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	33.3% 1/3 • From first dose to 100 days post last dose (Up to 6 months)	37.5% 3/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	6.8% 4/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	33.3% 1/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Metabolism and nutrition disorders Hypophosphataemia	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	33.3% 1/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	20.0% 2/10 • From first dose to 100 days post last dose (Up to 6 months)	6.8% 4/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Metabolism and nutrition disorders Increased appetite	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	13.3% 4/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Back pain	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 2/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	16.9% 10/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	5.1% 3/59 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 2/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 3/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Groin pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	33.3% 1/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	30.0% 3/10 • From first dose to 100 days post last dose (Up to 6 months)	8.5% 5/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	6.8% 4/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	13.3% 4/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Musculoskeletal pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	20.0% 2/10 • From first dose to 100 days post last dose (Up to 6 months)	11.9% 7/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 2/4 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 3/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	5.1% 3/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	5.1% 3/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	6.8% 4/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Nervous system disorders Dizziness	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 2/8 • From first dose to 100 days post last dose (Up to 6 months)	30.0% 3/10 • From first dose to 100 days post last dose (Up to 6 months)	8.5% 5/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Nervous system disorders Dysarthria	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Nervous system disorders Dysgeusia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	10.2% 6/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 2/4 • From first dose to 100 days post last dose (Up to 6 months)	13.3% 4/30 • From first dose to 100 days post last dose (Up to 6 months)
Nervous system disorders Headache	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	30.0% 3/10 • From first dose to 100 days post last dose (Up to 6 months)	10.2% 6/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	13.3% 4/30 • From first dose to 100 days post last dose (Up to 6 months)
Nervous system disorders Horner's syndrome	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Nervous system disorders Neuropathy peripheral	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	6.8% 4/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Nervous system disorders Peripheral sensory neuropathy	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	5.1% 3/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Nervous system disorders Seizure	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Nervous system disorders Somnolence	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Psychiatric disorders Abnormal dreams	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Psychiatric disorders Anxiety	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	5.1% 3/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Psychiatric disorders Confusional state	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Psychiatric disorders Delirium	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Psychiatric disorders Depression	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Psychiatric disorders Hallucination	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Psychiatric disorders Hallucination, auditory	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Psychiatric disorders Insomnia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 2/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	6.8% 4/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	20.0% 6/30 • From first dose to 100 days post last dose (Up to 6 months)
Renal and urinary disorders Acute kidney injury	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Renal and urinary disorders Chromaturia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Renal and urinary disorders Nocturia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Renal and urinary disorders Proteinuria	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Renal and urinary disorders Urinary retention	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Renal and urinary disorders Urine odour abnormal	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Reproductive system and breast disorders Pelvic pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Reproductive system and breast disorders Testicular pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	33.3% 1/3 • From first dose to 100 days post last dose (Up to 6 months)	37.5% 3/8 • From first dose to 100 days post last dose (Up to 6 months)	20.0% 2/10 • From first dose to 100 days post last dose (Up to 6 months)	22.0% 13/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	16.7% 5/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Dysphonia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	50.0% 5/10 • From first dose to 100 days post last dose (Up to 6 months)	32.2% 19/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	16.7% 5/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	5.1% 3/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Haemoptysis	50.0% 1/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Hiccups	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	20.0% 2/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	33.3% 1/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Pleuritic pain	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	30.0% 3/10 • From first dose to 100 days post last dose (Up to 6 months)	11.9% 7/59 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 2/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 3/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Productive cough	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	11.9% 7/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Rales	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Respiratory, thoracic and mediastinal disorders Throat irritation	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 3/30 • From first dose to 100 days post last dose (Up to 6 months)
Skin and subcutaneous tissue disorders Night sweats	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	33.3% 1/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	20.0% 2/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 1/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	20.0% 6/30 • From first dose to 100 days post last dose (Up to 6 months)
Skin and subcutaneous tissue disorders Rash	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	6.8% 4/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	13.3% 4/30 • From first dose to 100 days post last dose (Up to 6 months)
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	33.3% 1/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	3.3% 1/30 • From first dose to 100 days post last dose (Up to 6 months)
Skin and subcutaneous tissue disorders Rash papular	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	10.0% 3/30 • From first dose to 100 days post last dose (Up to 6 months)
Skin and subcutaneous tissue disorders Skin odour abnormal	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	25.0% 1/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Vascular disorders Flushing	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Vascular disorders Hypertension	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	3.4% 2/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	6.7% 2/30 • From first dose to 100 days post last dose (Up to 6 months)
Vascular disorders Hypotension	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	20.0% 2/10 • From first dose to 100 days post last dose (Up to 6 months)	1.7% 1/59 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)
Vascular disorders Systolic hypertension	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/2 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/3 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/10 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/59 • From first dose to 100 days post last dose (Up to 6 months)	12.5% 1/8 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/4 • From first dose to 100 days post last dose (Up to 6 months)	0.00% 0/30 • From first dose to 100 days post last dose (Up to 6 months)

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: Please Email:

Email: Clinical.Trials@bms.com

Results disclosure agreements

• Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
• Publication restrictions are in place

Restriction type: OTHER