Trial Outcomes & Findings for A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer (NCT NCT04730349)

NCT ID: NCT04730349

Last Updated: 2023-03-24

Results Overview

Number of participants with dose-limiting toxicities (DLTs). DLTs were collected and evaluated for Part A within the DLT evaluation period, which started on Cycle 1 Day 1 (first dose) and ended at Day 42 (42 days after first dose of the study therapy).

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 15 participants
• Primary outcome timeframe: From first dose to 42 days after first dose
• Results posted on: 2023-03-24

Participant Flow

15 participants were treated in Part A. Study did not progress to Part B; therefore, no participants enrolled in Part B.

Participant milestones

Measure	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Overall Study STARTED	8	7
Overall Study COMPLETED	1	2
Overall Study NOT COMPLETED	7	5

Reasons for withdrawal

Measure	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Overall Study Participant withdrew consent	1	0
Overall Study Disease progression	6	4
Overall Study Study drug toxicity	0	1

Baseline Characteristics

A Study of Bempegaldesleukin (BEMPEG: NKTR-214) in Combination With Nivolumab in Children, Adolescents and Young Adults With Recurrent or Treatment-resistant Cancer

Baseline characteristics by cohort

Measure	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) n=8 Participants Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) n=7 Participants Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks	Total n=15 Participants Total of all reporting groups
Age, Continuous	7.5 Years STANDARD_DEVIATION 3.9 • n=5 Participants	14.9 Years STANDARD_DEVIATION 1.5 • n=7 Participants	10.9 Years STANDARD_DEVIATION 4.8 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	5 Participants n=7 Participants	9 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Race/Ethnicity, Customized White	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose to 42 days after first dose

Population: All treated participants in Part A

Number of participants with dose-limiting toxicities (DLTs). DLTs were collected and evaluated for Part A within the DLT evaluation period, which started on Cycle 1 Day 1 (first dose) and ended at Day 42 (42 days after first dose of the study therapy).

Outcome measures

Measure	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) n=8 Participants Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) n=7 Participants Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Number of Participants With Dose-Limiting Toxicities (DLTs) - Part A	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Population: All treated participants in Part A

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

Outcome measures

Measure	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) n=8 Participants Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) n=7 Participants Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Number of Participants With Adverse Events (AEs) - Part A	8 Participants	7 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Population: All treated participants in Part A

Number of participants with serious adverse events (SAEs). SAE is defined as any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or causes prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event.

Outcome measures

Measure	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) n=8 Participants Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) n=7 Participants Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Number of Participants With Serious Adverse Events (SAEs) - Part A	6 Participants	5 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Population: All treated participants in Part A

Number of participants with drug-related adverse events. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Outcome measures

Measure	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) n=8 Participants Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) n=7 Participants Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Number of Participants With Drug-Related Adverse Events - Part A	6 Participants	6 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Population: All treated participants in Part A

Number of participants with adverse events leading to discontinuation. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Outcome measures

Measure	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) n=8 Participants Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) n=7 Participants Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Number of Participants With Adverse Events Leading to Discontinuation - Part A	2 Participants	3 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Population: All treated participants in Part A

Number of participants who died.

Outcome measures

Measure	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) n=8 Participants Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) n=7 Participants Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Number of Participants Who Died - Part A	2 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Population: Data was not and will never be collected

Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Population: Data was not and will never be collected

Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: From first dose to 30 days after last dose (up to approximately 6 months)

Population: Data was not and will never be collected

Pharmacokinetics (PK) of bempegaldesleukin and nivolumab derived from serum concentration versus time data.

Outcome measures

Outcome data not reported

Adverse Events

Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg)

Serious events: 8 serious events

Other events: 8 other events

Deaths: 7 deaths

Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg)

Serious events: 5 serious events

Other events: 7 other events

Deaths: 2 deaths

Serious adverse events

Measure	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) n=8 participants at risk Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) n=7 participants at risk Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Blood and lymphatic system disorders Thrombocytopenia	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
General disorders Chest pain	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
General disorders Influenza like illness	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
General disorders Pain	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
General disorders Pyrexia	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Injury, poisoning and procedural complications Skin wound	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Metabolism and nutrition disorders Dehydration	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	75.0% 6/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Nervous system disorders Brain oedema	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Nervous system disorders Seizure	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Renal and urinary disorders Nephrotic syndrome	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Cough	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Hypoxia	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Pleural effusion	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Respiratory failure	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).

Other adverse events

Measure	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (4.5 mg/kg) n=8 participants at risk Bempegaldesleukin 0.006 mg/kg + Nivolumab 4.5 mg/kg administered intravenously every 3 weeks	Part A: Bempegaldesleukin (0.006 mg/kg)+ Nivolumab (360 mg) n=7 participants at risk Bempegaldesleukin 0.006 mg/kg + Nivolumab 360 mg administered intravenously every 3 weeks
Blood and lymphatic system disorders Anaemia	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Blood and lymphatic system disorders Eosinophilia	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Blood and lymphatic system disorders Thrombocytopenia	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Cardiac disorders Sinus bradycardia	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Cardiac disorders Sinus tachycardia	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Ear and labyrinth disorders Hypoacusis	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Endocrine disorders Hyperthyroidism	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Endocrine disorders Hypothyroidism	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Eye disorders Eye pain	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Eye disorders Photophobia	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Gastrointestinal disorders Abdominal pain	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Gastrointestinal disorders Constipation	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Gastrointestinal disorders Nausea	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Gastrointestinal disorders Tooth discolouration	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Gastrointestinal disorders Vomiting	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
General disorders Asthenia	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
General disorders Chest pain	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
General disorders Chills	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
General disorders Fatigue	50.0% 4/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
General disorders Generalised oedema	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
General disorders Non-cardiac chest pain	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
General disorders Oedema peripheral	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
General disorders Pain	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
General disorders Pyrexia	25.0% 2/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Infections and infestations COVID-19	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Infections and infestations Conjunctivitis	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Infections and infestations Cystitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Infections and infestations Lymphangitis	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Infections and infestations Pharyngitis	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Infections and infestations Rhinitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Infections and infestations Vaginal infection	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Injury, poisoning and procedural complications Infusion related reaction	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Injury, poisoning and procedural complications Ligament sprain	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Investigations Alanine aminotransferase increased	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Investigations Aspartate aminotransferase increased	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Investigations Blood alkaline phosphatase increased	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Investigations C-reactive protein increased	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Investigations Gamma-glutamyltransferase increased	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Investigations Lymphocyte count decreased	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Investigations Neutrophil count decreased	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Investigations White blood cell count decreased	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Metabolism and nutrition disorders Decreased appetite	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Metabolism and nutrition disorders Hypoalbuminaemia	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	42.9% 3/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Musculoskeletal and connective tissue disorders Pain in extremity	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour haemorrhage	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Nervous system disorders Ataxia	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Nervous system disorders Dizziness	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Nervous system disorders Dysgeusia	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Nervous system disorders Headache	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Nervous system disorders Neuralgia	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Nervous system disorders Presyncope	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Psychiatric disorders Behaviour disorder	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Psychiatric disorders Insomnia	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Psychiatric disorders Sleep disorder	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Renal and urinary disorders Urinary incontinence	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Reproductive system and breast disorders Scrotal oedema	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Cough	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Dyspnoea	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Hypoxia	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Lung disorder	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Nasal congestion	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Pneumothorax	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Skin and subcutaneous tissue disorders Dermatitis allergic	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Skin and subcutaneous tissue disorders Photosensitivity reaction	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Skin and subcutaneous tissue disorders Pruritus	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Skin and subcutaneous tissue disorders Rash	37.5% 3/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	28.6% 2/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Skin and subcutaneous tissue disorders Urticaria	12.5% 1/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	0.00% 0/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).
Vascular disorders Hypotension	0.00% 0/8 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 months).	14.3% 1/7 • Participants were assessed for all-cause mortality from their first dose until study completion (up to approximately 13 months). SAEs and Other AEs were assessed from first dose to 150 days after last dose of study therapy (up to approximately 11 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