Trial Outcomes & Findings for A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection (NCT NCT05297565)

Last Updated: 2025-02-27

Results Overview

An adverse event (AE) is defined as any new untoward medical occurrence or worsening of a pre-existing medical condition in a clinical investigation participant administered study treatment that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (such as an abnormal laboratory finding), symptom, or disease temporally associated with the use of study treatment, whether or not considered related to the study treatment.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

14 participants

Primary outcome timeframe

From first dose to 100 days post last dose (Approximately up to 14 Months)

Results posted on

2025-02-27

Participant Flow

14 participants were randomized and treated

Participant milestones

Participant milestones
Measure	Arm A Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1.	Arm B * Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. * Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks. * All dosing will be performed in-clinic.
Overall Study STARTED	6	8
Overall Study COMPLETED	5	6
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1.	Arm B * Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. * Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks. * All dosing will be performed in-clinic.
Overall Study Other Reasons	0	1
Overall Study Physician Decision	0	1
Overall Study Disease recurrence	1	0

Baseline Characteristics

A Study to Compare Nivolumab Administered Subcutaneously vs Intravenous in Melanoma Participants Following Complete Resection

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: From first dose to 100 days post last dose (Approximately up to 14 Months)

Population: All Treated Participants

Outcome measures

Outcome measures
Measure	Arm A n=6 Participants Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1.	Arm B n=8 Participants * Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. * Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks. * All dosing will be performed in-clinic.
Number of Participants With Adverse Events Any Grade	6 Participants	8 Participants
Number of Participants With Adverse Events Grade 3 to 4	0 Participants	2 Participants
Number of Participants With Adverse Events Grade 5	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose to 100 days post last dose (Approximately up to 14 Months)

Population: All Treated Participants

A serious adverse event (SAE) is defined as any untoward medical occurrence that, at any dose: * Results in death. * Is life-threatening (defined as an event in which the participant was at risk of death at the time of the event; it does not refer to an event which hypothetically might have caused death if it were more severe). * Requires inpatient hospitalization or causes prolongation of existing hospitalization.

Outcome measures

Outcome measures
Measure	Arm A n=6 Participants Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1.	Arm B n=8 Participants * Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. * Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks. * All dosing will be performed in-clinic.
Number of Participants With Serious Adverse Events Any Grade	0 Participants	0 Participants
Number of Participants With Serious Adverse Events Grade 3 to 4	0 Participants	0 Participants
Number of Participants With Serious Adverse Events Grade 5	0 Participants	0 Participants

PRIMARY outcome

Timeframe: From first dose to 100 days post last dose (Approximately up to 14 Months)

Population: All Treated Participants

Outcome measures

Outcome measures
Measure	Arm A n=6 Participants Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1.	Arm B n=8 Participants * Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. * Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks. * All dosing will be performed in-clinic.
Number of Participants With Treatment Related Adverse Events Any Grade	6 Participants	8 Participants
Number of Participants With Treatment Related Adverse Events Grade 5	0 Participants	0 Participants
Number of Participants With Treatment Related Adverse Events Grade 3 to 4	0 Participants	2 Participants

PRIMARY outcome

Timeframe: From first dose to 100 days post last dose (Approximately up to 14 Months)

Population: All Treated Participants

Outcome measures

Outcome measures
Measure	Arm A n=6 Participants Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1.	Arm B n=8 Participants * Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. * Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks. * All dosing will be performed in-clinic.
Number of Participants With Treatment Related Serious Adverse Events Any Grade	0 Participants	0 Participants
Number of Participants With Treatment Related Serious Adverse Events Grade 3 to 4	0 Participants	0 Participants
Number of Participants With Treatment Related Serious Adverse Events Grade 5	0 Participants	0 Participants

Adverse Events

Arm A

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Arm B

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Additional Information

Bristol-Myers Squibb Study Director

Bristol-Myers Squibb

Phone: 1-855-907-3286

Email: [email protected]

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

Measure	Arm A n=6 Participants Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1.	Arm B n=8 Participants * Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. * Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks. * All dosing will be performed in-clinic.	Total n=14 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 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	6 Participants n=5 Participants	8 Participants n=7 Participants	14 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	0 Participants n=7 Participants	0 Participants n=5 Participants

Other adverse events
Measure	Arm A n=6 participants at risk Nivo SC (BMS-986298) 600 mg with 8,000 U of rHuPH20 administered via 2 sequential injections Q2W. Nivo SC will be administered in-clinic through cycle 5, Day 1.	Arm B n=8 participants at risk * Nivo IV (BMS-936558) 240 mg Q2W for Cycles 1 through 4. * Nivo IV 480 mg Q4W Cycle 5 onwards for up to total of 52 weeks. * All dosing will be performed in-clinic.
Blood and lymphatic system disorders Anaemia	0.00% 0/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 discomfort	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	0.00% 0/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	50.0% 3/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Dry mouth	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	25.0% 2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Dyspepsia	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 toxicity	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Tongue pruritus	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Administration site reaction	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	66.7% 4/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Device related thrombosis	0.00% 0/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	0.00% 0/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Impaired healing	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 pain	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	0.00% 0/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Puncture site erythema	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Puncture site inflammation	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Puncture site pain	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Puncture site pruritus	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Anal abscess	0.00% 0/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Body tinea	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Bronchiolitis	0.00% 0/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Conjunctivitis	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Diverticulitis	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Gastrointestinal viral infection	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Influenza	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	25.0% 2/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Nasopharyngitis	33.3% 2/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Oral herpes	0.00% 0/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Multiple injuries	0.00% 0/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Skin laceration	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 bilirubin increased	16.7% 1/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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% 0/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 glucose increased	0.00% 0/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Haemoglobin decreased	0.00% 0/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at 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 Lipase increased	0.00% 0/6 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication	12.5% 1/8 • Adverse Events and Serious Adverse Events: (From first dose to last dose + 100 days): Approximately 14 Months All-Cause mortality (From randomization to end of study): Approximately 14 Months The number at Risk for All-Cause Mortality represents all Randomized Participants. The number at Risk for Serious Adverse Events and Other (Not Including Serious) Adverse Events represents all participants that received at least 1 dose of study medication