Trial Outcomes & Findings for Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045) (NCT NCT04054193)

Last Updated: 2025-01-16

Results Overview

An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a study drug, whether or not it is considered related to the study drug. The percentage of participants in Cycle 1 who experience one or more AE(s) is presented.

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

103 participants

Primary outcome timeframe

Up to 17 days

Results posted on

2025-01-16

Participant Flow

Eligible participants were recruited at 25 study sites in 9 countries.

Participant milestones

Participant milestones
Measure	Fosaprepitant Treatment Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during the 17-day Cycle 1. Participants also optionally received dexamethasone as background therapy, and a serotonin (5-hydroxytryptamine \[5-HT\]) 3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy. After completing Cycle 1, participants had the option to continue for up to 2 additional 17-day cycles of the same treatment regimen.
Cycle 1 STARTED	103
Cycle 1 Treated (≥1 Dose)	100
Cycle 1 COMPLETED	98
Cycle 1 NOT COMPLETED	5
Cycles 2-3 STARTED	69
Cycles 2-3 COMPLETED	48
Cycles 2-3 NOT COMPLETED	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Fosaprepitant Treatment Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during the 17-day Cycle 1. Participants also optionally received dexamethasone as background therapy, and a serotonin (5-hydroxytryptamine \[5-HT\]) 3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy. After completing Cycle 1, participants had the option to continue for up to 2 additional 17-day cycles of the same treatment regimen.
Cycle 1 Physician Decision	1
Cycle 1 Consent withdrawn by parent/guardian	1
Cycle 1 Allocated but not treated	3
Cycles 2-3 Physician Decision	2
Cycles 2-3 Consent withdrawn by parent/guardian	2
Cycles 2-3 Various reasons	17

Baseline Characteristics

Safety of a Three-Day Fosaprepitant Regimen for the Prevention of Chemotherapy-Induced Nausea and Vomiting in Pediatric Participants (MK-0517-045)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fosaprepitant Treatment n=103 Participants Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during the 17-day Cycle 1. Participants also optionally received dexamethasone as background therapy, and a serotonin (5-hydroxytryptamine \[5-HT\]) 3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy. After completing Cycle 1, participants had the option to continue for up to 2 additional 17-day cycles of the same treatment regimen.
Age, Continuous	7.7 Years STANDARD_DEVIATION 5.0 • n=5 Participants
Sex: Female, Male Female	50 Participants n=5 Participants
Sex: Female, Male Male	53 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	77 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	14 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	81 Participants n=5 Participants
Race (NIH/OMB) More than one race	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Up to 17 days

Population: The analysis population consists of all allocated participants in Cycle 1 who received ≥1 dose of study intervention.

Outcome measures

Outcome measures
Measure	Fosaprepitant Treatment n=100 Participants Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during the 17-day Cycle 1. Participants also optionally received dexamethasone as background therapy, and a serotonin (5-hydroxytryptamine \[5-HT\]) 3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy. After completing Cycle 1, participants had the option to continue for up to 2 additional 17-day cycles of the same treatment regimen.
Percentage of Participants in Cycle 1 Who Experienced One or More Adverse Events (AEs)	80.0 Percentage of Participants

PRIMARY outcome

Timeframe: Up to 3 days

Population: The analysis population consists of all allocated participants in Cycle 1 who received ≥1 dose of study intervention.

Outcome measures

Outcome measures
Measure	Fosaprepitant Treatment n=100 Participants Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during the 17-day Cycle 1. Participants also optionally received dexamethasone as background therapy, and a serotonin (5-hydroxytryptamine \[5-HT\]) 3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy. After completing Cycle 1, participants had the option to continue for up to 2 additional 17-day cycles of the same treatment regimen.
Percentage of Participants in Cycle 1 Who Discontinued Study Drug Due to an Adverse Event (AE)	2.0 Percentage of Participants

Adverse Events

Fosaprepitant Cycle 1

Serious events: 30 serious events

Other events: 64 other events

Deaths: 0 deaths

Fosaprepitant Cycles 2-3

Serious events: 27 serious events

Other events: 27 other events

Deaths: 0 deaths

Serious adverse events

Other adverse events

Other adverse events
Measure	Fosaprepitant Cycle 1 n=100 participants at risk Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during the 17-day Cycle 1. Participants also optionally received dexamethasone as background therapy, and a serotonin (5-hydroxytryptamine \[5-HT\]) 3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy.	Fosaprepitant Cycles 2-3 n=69 participants at risk Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during Cycles 2-3. Participants also optionally received dexamethasone as background therapy, and a 5-HT3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy, of each 17-day cycle.
Blood and lymphatic system disorders Anaemia	24.0% 24/100 • Number of events 28 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	10.1% 7/69 • Number of events 8 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Blood and lymphatic system disorders Haematotoxicity	9.0% 9/100 • Number of events 9 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	14.5% 10/69 • Number of events 15 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Blood and lymphatic system disorders Neutropenia	15.0% 15/100 • Number of events 16 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	5.8% 4/69 • Number of events 4 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Blood and lymphatic system disorders Thrombocytopenia	11.0% 11/100 • Number of events 11 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	4.3% 3/69 • Number of events 3 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Gastrointestinal disorders Constipation	6.0% 6/100 • Number of events 6 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	4.3% 3/69 • Number of events 3 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Gastrointestinal disorders Nausea	24.0% 24/100 • Number of events 25 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	11.6% 8/69 • Number of events 9 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Gastrointestinal disorders Vomiting	16.0% 16/100 • Number of events 18 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	11.6% 8/69 • Number of events 13 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Investigations Neutrophil count decreased	14.0% 14/100 • Number of events 14 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	2.9% 2/69 • Number of events 2 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Investigations Platelet count decreased	9.0% 9/100 • Number of events 9 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	5.8% 4/69 • Number of events 4 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Investigations White blood cell count decreased	7.0% 7/100 • Number of events 8 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	1.4% 1/69 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Metabolism and nutrition disorders Decreased appetite	6.0% 6/100 • Number of events 6 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	0.00% 0/69 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee If publication activity is not directed by the Sponsor, the investigator agrees to submit all manuscripts or abstracts to the Sponsor before submission.
Publication restrictions are in place

Restriction type: OTHER

Measure	Fosaprepitant Cycle 1 n=100 participants at risk Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during the 17-day Cycle 1. Participants also optionally received dexamethasone as background therapy, and a serotonin (5-hydroxytryptamine \[5-HT\]) 3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy.	Fosaprepitant Cycles 2-3 n=69 participants at risk Participants received fosaprepitant dimeglumine once daily (QD) for 3 days and were followed for 14 days during Cycles 2-3. Participants also optionally received dexamethasone as background therapy, and a 5-HT3 receptor antagonist on Day 1 and optionally on Days 2-3 as background therapy, of each 17-day cycle.
Blood and lymphatic system disorders Anaemia	1.0% 1/100 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	5.8% 4/69 • Number of events 5 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Blood and lymphatic system disorders Febrile neutropenia	17.0% 17/100 • Number of events 18 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	21.7% 15/69 • Number of events 20 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Gastrointestinal disorders Nausea	2.0% 2/100 • Number of events 2 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	0.00% 0/69 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Gastrointestinal disorders Stomatitis	2.0% 2/100 • Number of events 2 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	2.9% 2/69 • Number of events 3 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Gastrointestinal disorders Vomiting	1.0% 1/100 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	1.4% 1/69 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
General disorders Fatigue	1.0% 1/100 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	1.4% 1/69 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
General disorders Pyrexia	1.0% 1/100 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	1.4% 1/69 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Infections and infestations Herpes zoster	1.0% 1/100 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	0.00% 0/69 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Infections and infestations Pharyngitis	1.0% 1/100 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	0.00% 0/69 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Infections and infestations Pneumocystis jirovecii pneumonia	1.0% 1/100 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	0.00% 0/69 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Injury, poisoning and procedural complications Infusion related reaction	1.0% 1/100 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	0.00% 0/69 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Metabolism and nutrition disorders Decreased appetite	1.0% 1/100 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	0.00% 0/69 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Musculoskeletal and connective tissue disorders Back pain	1.0% 1/100 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	0.00% 0/69 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Nervous system disorders Coordination abnormal	1.0% 1/100 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	0.00% 0/69 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Blood and lymphatic system disorders Leukopenia	0.00% 0/100 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	2.9% 2/69 • Number of events 2 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/100 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	1.4% 1/69 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Blood and lymphatic system disorders Myelosuppression	0.00% 0/100 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	1.4% 1/69 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Blood and lymphatic system disorders Neutropenia	0.00% 0/100 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	2.9% 2/69 • Number of events 2 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Blood and lymphatic system disorders Thrombocytopenia	0.00% 0/100 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	4.3% 3/69 • Number of events 3 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Gastrointestinal disorders Abdominal pain	0.00% 0/100 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	1.4% 1/69 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Gastrointestinal disorders Colitis	0.00% 0/100 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	1.4% 1/69 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
General disorders Mucosal inflammation	0.00% 0/100 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	1.4% 1/69 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Infections and infestations Bacteraemia	0.00% 0/100 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	2.9% 2/69 • Number of events 2 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Infections and infestations Fungaemia	0.00% 0/100 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	1.4% 1/69 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Infections and infestations Upper respiratory tract infection	0.00% 0/100 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	1.4% 1/69 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Metabolism and nutrition disorders Hypomagnesaemia	0.00% 0/100 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	1.4% 1/69 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Skin and subcutaneous tissue disorders Stevens-Johnson syndrome	0.00% 0/100 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	1.4% 1/69 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Blood and lymphatic system disorders Haematotoxicity	1.0% 1/100 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	1.4% 1/69 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.
Blood and lymphatic system disorders Pancytopenia	1.0% 1/100 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.	1.4% 1/69 • Number of events 1 • Up to approximately 3.5 months All-cause mortality is reported for all allocated participants, and serious and nonserious adverse events are reported for all allocated participants who received ≥1 dose of study intervention. Findings from Cycle 1 and Cycles 2-3 are presented separately.