Trial Outcomes & Findings for A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer (NCT NCT05169684)

NCT ID: NCT05169684

Last Updated: 2025-06-10

Results Overview

Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 10 participants
• Primary outcome timeframe: From first dose to 100 days follow up to last dose (Approximately 22 months)
• Results posted on: 2025-06-10

Participant Flow

10 Participants enrolled and Treated. Study terminated early after safety lead in portion (part 1).

Participant milestones

Measure	Treatment 1 BMS-986218 30mg Q3W + Docetaxel 75 mg/m² Q3W	Treatment 2 BMS-986218 50mg Q3W + Docetaxel 75 mg/m² Q3W
Overall Study STARTED	3	7
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	2	7

Reasons for withdrawal

Measure	Treatment 1 BMS-986218 30mg Q3W + Docetaxel 75 mg/m² Q3W	Treatment 2 BMS-986218 50mg Q3W + Docetaxel 75 mg/m² Q3W
Overall Study Adverse Event	1	3
Overall Study Physician Decision	0	1
Overall Study Progressive Disease	1	1
Overall Study Participant request to discontinue treatment	0	1
Overall Study Other Reason	0	1

Baseline Characteristics

A Study of BMS-986218 or BMS-986218 Plus Nivolumab in Combination With Docetaxel in Participants With Metastatic Castration-resistant Prostate Cancer

Baseline characteristics by cohort

Measure	Treatment 1 n=3 Participants BMS-986218 30mg Q3W + Docetaxel 75 mg/m² Q3W	Treatment 2 n=7 Participants BMS-986218 50mg Q3W + Docetaxel 75 mg/m² Q3W	Total n=10 Participants Total of all reporting groups
Age, Continuous	68.3 Years STANDARD_DEVIATION 6.11 • n=5 Participants	65.7 Years STANDARD_DEVIATION 9.14 • n=7 Participants	66.5 Years STANDARD_DEVIATION 8.10 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	7 Participants n=7 Participants	10 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	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 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
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants	6 Participants n=7 Participants	9 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: From first dose to 100 days follow up to last dose (Approximately 22 months)

Population: All treated Participants in part 1

Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).

Outcome measures

Measure	Treatment 1 n=3 Participants BMS-986218 30mg Q3W + Docetaxel 75 mg/m² Q3W	Treatment 2 n=7 Participants BMS-986218 50mg Q3W + Docetaxel 75 mg/m² Q3W
Number of Participants With Treatment Related Adverse Events	3 Participants	7 Participants

PRIMARY outcome

Timeframe: From first dose to 100 days follow up to last dose (Approximately 22 months)

Population: All treated Participants in part 1

Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).

Outcome measures

Measure	Treatment 1 n=3 Participants BMS-986218 30mg Q3W + Docetaxel 75 mg/m² Q3W	Treatment 2 n=7 Participants BMS-986218 50mg Q3W + Docetaxel 75 mg/m² Q3W
Number of Participants With Treatment Related Serious Adverse Events	1 Participants	4 Participants

PRIMARY outcome

Timeframe: From first dose to 100 days follow up to last dose (Approximately 22 months)

Population: All treated Participants in part 1

DLTs will be defined as:

Any treatment-related AEs for which a participant permanently discontinues a study treatment (other than daily prednisone) and that occurs during the first 2 cycles of treatment.

Any death not clearly due to the underlying disease or extraneous causes and that occurs during the first 2 cycles of treatment Greater than or equal to Grade 2 pneumonitis lasting greater than 5 days despite appropriate medical therapy and that occurs during the first 2 cycles of treatment Any neutropenic fever as well as Grade 4 neutropenia or thrombocytopenia for > 7 days that occurs during the first 2 cycles of treatment Any treatment-related AE that delays initiation of Cycle 2 or Cycle 3 of treatment by greater than 2 consecutive weeks.

Outcome measures

Measure	Treatment 1 n=3 Participants BMS-986218 30mg Q3W + Docetaxel 75 mg/m² Q3W	Treatment 2 n=7 Participants BMS-986218 50mg Q3W + Docetaxel 75 mg/m² Q3W
Number of Participants With Dose Limiting Toxicities	1 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose to 100 days follow up to last dose (Approximately 22 months)

Population: All treated Participants in part 1

Adverse events will presented using National Cancer Institute Common Terminology Criteria for Adverse Events version 5 (NCI CTCAE v5).

Outcome measures

Measure	Treatment 1 n=3 Participants BMS-986218 30mg Q3W + Docetaxel 75 mg/m² Q3W	Treatment 2 n=7 Participants BMS-986218 50mg Q3W + Docetaxel 75 mg/m² Q3W
Number of Participants With AEs Leading to Discontinuation	2 Participants	4 Participants

PRIMARY outcome

Timeframe: From first dose to 100 days follow up to last dose (Approximately 22 months)

Population: All treated Participants in part 1

Number of participant deaths

Outcome measures

Measure	Treatment 1 n=3 Participants BMS-986218 30mg Q3W + Docetaxel 75 mg/m² Q3W	Treatment 2 n=7 Participants BMS-986218 50mg Q3W + Docetaxel 75 mg/m² Q3W
Number of Participants Who Died	2 Participants	2 Participants

SECONDARY outcome

Timeframe: From first dose to 100 days follow up to last dose (Approximately 22 months)

Population: PSA Evaluable Population

PSA-RR is the proportion of randomized participants with a 50% or greater decrease in PSA from baseline to any post-baseline PSA result. A second consecutive value obtained 3 or more weeks later is required to confirm the PSA response.

Outcome measures

Measure	Treatment 1 n=3 Participants BMS-986218 30mg Q3W + Docetaxel 75 mg/m² Q3W	Treatment 2 n=7 Participants BMS-986218 50mg Q3W + Docetaxel 75 mg/m² Q3W
Prostate Specific Antigen Response Rate (PSA-RR) Unconfirmed or Confirmed PSA responders	33.3 Percentage of Participants Interval 0.8 to 90.6	57.1 Percentage of Participants Interval 18.4 to 90.1
Prostate Specific Antigen Response Rate (PSA-RR) Confirmed PSA responders	33.3 Percentage of Participants Interval 0.8 to 90.6	57.1 Percentage of Participants Interval 18.4 to 90.1

SECONDARY outcome

Timeframe: From first dose to 100 days follow up to last dose (Approximately 22 months)

Population: Study was terminated after safety lead in portion of part 1. Efficacy Data in part 2 was not collected, which includes this endpoint.

Objective response rate per PCWG3 (ORR-PCWG3) is the proportion of participants who have a confirmed complete or partial best overall response (BOR) per PCWG3 among randomized participants who have measurable disease at baseline. The BOR is defined as the best response designation, as determined by the BICR, recorded between the date of randomization and the date of objectively documented radiographic progression, or last tumor measurement, whichever occurs first.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose to 100 days follow up to last dose (Approximately 22 months)

Population: Study was terminated after safety lead in portion of part 1. Efficacy Data in part 2 was not collected, which includes this endpoint.

Time to response per PCWG3 (TTR-PCWG3) is the time from randomization date to the date of the first documented CR or PR per PCWG3, as determined by BICR.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose to 100 days follow up to last dose (Approximately 22 months)

Population: Study was terminated after safety lead in portion of part 1. Efficacy Data in part 2 was not collected, which includes this endpoint.

Duration of response per PCWG3 (DOR-PCWG3) is the time between the date of first response (CR/PR per PCWG3) to the date of first documented radiographic progression per PCWG3 (as determined by BICR), or death due to any cause.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: From first dose to 100 days follow up to last dose (Approximately 22 months)

Population: Study was terminated after safety lead in portion of part 1. Efficacy Data in part 2 was not collected, which includes this endpoint.

OS for all randomized participants is the time between randomization date and the date of death from any cause.

Outcome measures

Outcome data not reported

Adverse Events

Treatment 1

Serious events: 1 serious events

Other events: 3 other events

Deaths: 2 deaths

Treatment 2

Serious events: 6 serious events

Other events: 7 other events

Deaths: 2 deaths

Serious adverse events

Measure	Treatment 1 n=3 participants at risk BMS-986218 30mg Q3W + Docetaxel 75 mg/m² Q3W	Treatment 2 n=7 participants at risk BMS-986218 50mg Q3W + Docetaxel 75 mg/m² Q3W
Blood and lymphatic system disorders Anaemia	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Diarrhoea	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Enterocolitis	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Gastrointestinal haemorrhage	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Small intestinal haemorrhage	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Small intestinal obstruction	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Pyrexia	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Enterocolitis infectious	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Rectal abscess	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Sepsis	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Fall	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Malignant neoplasm progression	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Metabolic encephalopathy	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Syncope	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Acute kidney injury	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary embolism	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypotension	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Shock haemorrhagic	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Vasculitis	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Other adverse events

Measure	Treatment 1 n=3 participants at risk BMS-986218 30mg Q3W + Docetaxel 75 mg/m² Q3W	Treatment 2 n=7 participants at risk BMS-986218 50mg Q3W + Docetaxel 75 mg/m² Q3W
Blood and lymphatic system disorders Anaemia	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	57.1% 4/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Blood and lymphatic system disorders Blood loss anaemia	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Ear and labyrinth disorders Tinnitus	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Adrenal insufficiency	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Endocrine disorders Hypothyroidism	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Eye disorders Eye disorder	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal distension	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Abdominal pain	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Ascites	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Bowel movement irregularity	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Colitis	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	57.1% 4/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Constipation	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Diarrhoea	100.0% 3/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	57.1% 4/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Dysphagia	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Enterocolitis	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Gastrointestinal haemorrhage	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Haematochezia	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Haemorrhoidal haemorrhage	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Haemorrhoids	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Lower gastrointestinal haemorrhage	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Mouth ulceration	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Nausea	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	71.4% 5/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Oral pain	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Proctitis	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Gastrointestinal disorders Vomiting	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Asthenia	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Chills	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Face oedema	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Fatigue	100.0% 3/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	57.1% 4/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Generalised oedema	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Influenza like illness	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Injection site reaction	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Localised oedema	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Malaise	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Mucosal inflammation	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Oedema peripheral	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Pyrexia	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	57.1% 4/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Swelling face	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
General disorders Terminal agitation	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Immune system disorders Drug hypersensitivity	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Immune system disorders Hypersensitivity	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations COVID-19	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Candida infection	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Cellulitis	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Rectal abscess	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Sinusitis	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Staphylococcal skin infection	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Submandibular abscess	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Tooth infection	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Upper respiratory tract infection	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Infections and infestations Urinary tract infection	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Fall	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Infusion related reaction	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Injury, poisoning and procedural complications Procedural pain	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Alanine aminotransferase increased	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Aspartate aminotransferase increased	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood alkaline phosphatase increased	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood creatinine increased	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood lactate dehydrogenase increased	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Blood thyroid stimulating hormone increased	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Influenza A virus test positive	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Lymphocyte count decreased	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Mycobacterium tuberculosis complex test positive	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Neutrophil count decreased	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Nitrite urine present	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Platelet count decreased	66.7% 2/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Prostatic specific antigen increased	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations Weight increased	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Investigations White blood cell count decreased	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Decreased appetite	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Dehydration	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypercalcaemia	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyperglycaemia	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypermagnesaemia	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypoalbuminaemia	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypocalcaemia	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypokalaemia	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypomagnesaemia	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	57.1% 4/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Back pain	66.7% 2/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Bone pain	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Muscular weakness	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Neck pain	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Pain in extremity	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Musculoskeletal and connective tissue disorders Sacral pain	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dizziness	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Dysgeusia	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Headache	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Neuropathy peripheral	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Paraesthesia	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Peripheral sensory neuropathy	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Presyncope	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Somnolence	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Nervous system disorders Syncope	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Confusional state	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Depression	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Psychiatric disorders Insomnia	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Acute kidney injury	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Cystitis noninfective	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Haematuria	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Proteinuria	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Renal and urinary disorders Urethral pain	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Cough	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Epistaxis	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Laryngeal inflammation	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Oropharyngeal pain	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Respiratory failure	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Respiratory, thoracic and mediastinal disorders Sleep apnoea syndrome	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Alopecia	66.7% 2/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Erythema	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Nail discolouration	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Night sweats	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash macular	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Rash maculo-papular	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	42.9% 3/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Skin disorder	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	0.00% 0/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Skin exfoliation	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Skin hyperpigmentation	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Skin and subcutaneous tissue disorders Skin ulcer	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Flushing	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hot flush	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	28.6% 2/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypertension	33.3% 1/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Hypotension	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	71.4% 5/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication
Vascular disorders Orthostatic hypotension	0.00% 0/3 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	14.3% 1/7 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 22 Months All-Cause mortality (From randomization to end of study): Approximately 22 Months. The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication

Additional Information

Bristol-Myers Squibb Study Director

Bristol Myers Squibb

Phone: 1-855-907-3286

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