Trial Outcomes & Findings for Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029) (NCT NCT01697579)

NCT ID: NCT01697579

Last Updated: 2019-06-25

Results Overview

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 240 participants
• Primary outcome timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion
• Results posted on: 2019-06-25

Participant Flow

This study enrolled participants scheduled to receive chemotherapeutic agent(s) associated with moderate, high, or very high risk of emetogenicity for no more than 5 consecutive days and were expected to receive ondansetron as part of their antiemetic regimen. Additional inclusion and exclusion criteria applied.

Participants (2 to <6, 6 to <12 and 12 to17 years-old) were enrolled in a randomized, partially-blinded study of 4 doses of fosaprepitant and a control in Cycle 1. Participants (0 to <2, 2 to <6 and 6 to <12 years-old) were invited to participate in optional Cycles 2-6 which was an open-label study of 2 doses of fosaprepitant.

Participant milestones

Measure	Fosaprepitant 5 mg/Kg-Cycle 1 Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/Kg-Cycle 1 Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/Kg-Cycle 1 Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/Kg-Cycle 1 Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 5 mg/Kg-Cycles 2-6 For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.	Fosaprepitant 3 mg/Kg-Cycles 2-6 For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.
Base Study-Cycle 1 STARTED	74	43	44	41	38	0	0
Base Study-Cycle 1 COMPLETED	72	42	43	40	35	0	0
Base Study-Cycle 1 NOT COMPLETED	2	1	1	1	3	0	0
Optional Extension-Cycles 2-6 STARTED	0	0	0	0	0	47	106
Optional Extension-Cycles 2-6 COMPLETED	0	0	0	0	0	12	37
Optional Extension-Cycles 2-6 NOT COMPLETED	0	0	0	0	0	35	69

Reasons for withdrawal

Measure	Fosaprepitant 5 mg/Kg-Cycle 1 Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/Kg-Cycle 1 Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/Kg-Cycle 1 Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/Kg-Cycle 1 Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 5 mg/Kg-Cycles 2-6 For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.	Fosaprepitant 3 mg/Kg-Cycles 2-6 For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.
Base Study-Cycle 1 Adverse Event	1	0	0	0	0	0	0
Base Study-Cycle 1 Withdrawal by Parent/Guardian	1	0	0	0	0	0	0
Base Study-Cycle 1 Protocol Violation	0	0	0	0	3	0	0
Base Study-Cycle 1 Consent Withdrawn by Participant	0	1	0	0	0	0	0
Base Study-Cycle 1 Technical Problems	0	0	1	1	0	0	0
Optional Extension-Cycles 2-6 Death	0	0	0	0	0	0	2
Optional Extension-Cycles 2-6 Withdrawal by Parent/Guardian	0	0	0	0	0	1	5
Optional Extension-Cycles 2-6 Physician Decision	0	0	0	0	0	7	11
Optional Extension-Cycles 2-6 Protocol Violation	0	0	0	0	0	0	4
Optional Extension-Cycles 2-6 Excluded Medication	0	0	0	0	0	1	2
Optional Extension-Cycles 2-6 Did Not Respond To Chemotherapy Regimen	0	0	0	0	0	1	0
Optional Extension-Cycles 2-6 Completed Chemotherapy Regimen	0	0	0	0	0	15	24
Optional Extension-Cycles 2-6 Did Not Meet Cycle Eligibility Criteria	0	0	0	0	0	4	11
Optional Extension-Cycles 2-6 Consent Withdrawn by Participant	0	0	0	0	0	0	2
Optional Extension-Cycles 2-6 Technical Problems	0	0	0	0	0	0	1
Optional Extension-Cycles 2-6 Participant Moved	0	0	0	0	0	0	2
Optional Extension-Cycles 2-6 Non-compliance With Protocol	0	0	0	0	0	6	4
Optional Extension-Cycles 2-6 Lost to Follow-up	0	0	0	0	0	0	1

Baseline Characteristics

Study of the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of Fosaprepitant for the Prevention of Chemotherapy-Induced Nausea and Vomiting (CINV) in Children (MK-0517-029)

Baseline characteristics by cohort

Measure	Fosaprepitant 5 mg/Kg-Cycle 1 n=74 Participants Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/Kg-Cycle 1 n=43 Participants Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/Kg-Cycle 1 n=44 Participants Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/Kg-Cycle 1 n=41 Participants Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 n=38 Participants Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Total n=240 Participants Total of all reporting groups
Age, Continuous	60.2 Months STANDARD_DEVIATION 42.3 • n=5 Participants	123.8 Months STANDARD_DEVIATION 51.3 • n=7 Participants	119.4 Months STANDARD_DEVIATION 52.7 • n=5 Participants	119.2 Months STANDARD_DEVIATION 54.3 • n=4 Participants	122.5 Months STANDARD_DEVIATION 54.0 • n=21 Participants	102.4 Months STANDARD_DEVIATION 57.0 • n=10 Participants
Sex: Female, Male Female	32 Participants n=5 Participants	18 Participants n=7 Participants	23 Participants n=5 Participants	19 Participants n=4 Participants	19 Participants n=21 Participants	111 Participants n=10 Participants
Sex: Female, Male Male	42 Participants n=5 Participants	25 Participants n=7 Participants	21 Participants n=5 Participants	22 Participants n=4 Participants	19 Participants n=21 Participants	129 Participants n=10 Participants

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 0 to \<2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=22 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Maximum Concentration (Cmax) of Aprepitant in Participants 0 to <2 Years of Age	3550 ng/mL Standard Deviation 1500	—	—	—	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 0 to \<2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=22 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Time to Maximum Concentration (Tmax) of Aprepitant in Participants 0 to <2 Years of Age	2.01 hours Standard Deviation 2.10	—	—	—	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 0 to \<2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=16 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Area Under the Concentration-time Curve of Aprepitant From Time 0 to Infinity (AUC 0-∞) in Participants 0 to <2 Years of Age	37200 hr•ng/mL Standard Deviation 15800	—	—	—	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 0 to \<2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=21 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Area Under the Concentration-time Curve of Aprepitant From Time 0 to 24 Hours (AUC 0-24hr) in Participants 0 to <2 Years of Age	36800 hr•ng/mL Standard Deviation 21800	—	—	—	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 0 to \<2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=16 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Apparent Terminal Half-life (t1/2) of Aprepitant in Participants 0 to <2 Years of Age	7.94 hours Standard Deviation 2.86	—	—	—	—

PRIMARY outcome

Timeframe: Approximately 24 hours (from 23 to 25 hours) post-infusion

Population: All participants 0 to \<2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=21 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Concentration of Aprepitant After 24 Hours (C24hr) in Participants 0 to <2 Years of Age	691 ng/mL Standard Deviation 852	—	—	—	—

PRIMARY outcome

Timeframe: Approximately 48 hours (from 46 to 50 hours) post-infusion

Population: All participants 0 to \<2 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=10 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Concentration of Aprepitant After 48 Hours (C48hr) in Participants 0 to <2 Years of Age	352 ng/mL Standard Deviation 929	—	—	—	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 0 to \<2 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=16 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Apparent Total Body Clearance (CL/F) of Aprepitant in Participants 0 to <2 Years of Age	24.2 mL/min Standard Deviation 11.9	—	—	—	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 2 to \<6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=25 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=6 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=8 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 n=6 Participants Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Cmax of Aprepitant in Participants 2 to <6 Years of Age	4270 ng/mL Standard Deviation 2370	2320 ng/mL Standard Deviation 1540	2030 ng/mL Standard Deviation 1780	323 ng/mL Standard Deviation 103	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 2 to \<6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=25 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=6 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=8 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 n=6 Participants Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Tmax of Aprepitant in Participants 2 to <6 Years of Age	1.90 hours Standard Deviation 2.16	2.29 hours Standard Deviation 2.14	1.36 hours Standard Deviation 0.868	1.34 hours Standard Deviation 0.771	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 2 to \<6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=20 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=5 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=5 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 n=4 Participants Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
AUC 0-∞ of Aprepitant in Participants 2 to <6 Years of Age	46400 hr•ng/mL Standard Deviation 18600	15300 hr•ng/mL Standard Deviation 11100	16000 hr•ng/mL Standard Deviation 9680	2070 hr•ng/mL Standard Deviation 992	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 2 to \<6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=25 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=6 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=8 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 n=5 Participants Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
AUC 0-24hr of Aprepitant in Participants 2 to <6 Years of Age	45000 hr•ng/mL Standard Deviation 23800	21800 hr•ng/mL Standard Deviation 22200	19700 hr•ng/mL Standard Deviation 18500	1840 hr•ng/mL Standard Deviation 742	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 2 to \<6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=20 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=5 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=5 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 n=4 Participants Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
t1/2 of Aprepitant in Participants 2 to <6 Years of Age	9.27 hours Standard Deviation 4.17	6.55 hours Standard Deviation 3.62	7.27 hours Standard Deviation 3.47	6.18 hours Standard Deviation 3.51	—

PRIMARY outcome

Timeframe: Approximately 24 hours (from 23 to 25 hours) post-infusion

Population: All participants 2 to \<6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=25 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=6 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=8 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 n=6 Participants Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
C24hr of Aprepitant in Participants 2 to <6 Years of Age	1060 ng/mL Standard Deviation 1020	278 ng/mL Standard Deviation 398	332 ng/mL Standard Deviation 430	9.23 ng/mL Standard Deviation 14.8	—

PRIMARY outcome

Timeframe: Approximately 48 hours (from 46 to 50 hours) post-infusion

Population: All participants 2 to \<6 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=20 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
C48hr of Aprepitant in Participants 2 to <6 Years of Age	232 ng/mL Standard Deviation 471	—	—	—	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 2 to \<6 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=20 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=5 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=5 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 n=4 Participants Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
CL/F of Aprepitant in Participants 2 to <6 Years of Age	31.8 mL/min Standard Deviation 13.8	66.2 mL/min Standard Deviation 25.5	29.6 mL/min Standard Deviation 22.1	48.5 mL/min Standard Deviation 28.4	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 6 to \<12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=24 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=14 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=13 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 n=12 Participants Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Cmax of Aprepitant in Participants 6 to <12 Years of Age	4400 ng/mL Standard Deviation 1910	3550 ng/mL Standard Deviation 2460	1360 ng/mL Standard Deviation 903	507 ng/mL Standard Deviation 443	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 6 to \<12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=24 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=14 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=13 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 n=12 Participants Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Tmax of Aprepitant in Participants 6 to <12 Years of Age	2.92 hours Standard Deviation 5.09	1.99 hours Standard Deviation 1.62	2.14 hours Standard Deviation 1.96	1.68 hours Standard Deviation 2.46	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 6 to \<12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=13 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=8 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=9 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 n=8 Participants Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
AUC 0-∞ of Aprepitant in Participants 6 to <12 Years of Age	55300 hr•ng/mL Standard Deviation 11900	34300 hr•ng/mL Standard Deviation 20300	10700 hr•ng/mL Standard Deviation 5440	2860 hr•ng/mL Standard Deviation 1120	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 6 to \<12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=23 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=14 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=13 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 n=12 Participants Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
AUC 0-24hr of Aprepitant in Participants 6 to <12 Years of Age	47400 hr•ng/mL Standard Deviation 17300	29200 hr•ng/mL Standard Deviation 14300	12000 hr•ng/mL Standard Deviation 11000	4260 hr•ng/mL Standard Deviation 5040	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 6 to \<12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=13 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=8 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=9 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 n=8 Participants Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
t1/2 of Aprepitant in Participants 6 to <12 Years of Age	9.77 hours Standard Deviation 2.49	7.69 hours Standard Deviation 2.09	8.23 hours Standard Deviation 1.83	6.58 hours Standard Deviation 2.36	—

PRIMARY outcome

Timeframe: Approximately 24 hours (from 23 to 25 hours) post-infusion

Population: All participants 6 to \<12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=24 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=14 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=13 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 n=12 Participants Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
C24hr of Aprepitant in Participants 6 to <12 Years of Age	1210 ng/mL Standard Deviation 1000	589 ng/mL Standard Deviation 433	219 ng/mL Standard Deviation 379	70.4 ng/mL Standard Deviation 136	—

PRIMARY outcome

Timeframe: Approximately 48 hours (from 46 to 50 hours) post-infusion

Population: All participants 6 to \<12 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=11 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
C48hr of Aprepitant in Participants 6 to <12 Years of Age	164 ng/mL Standard Deviation 124	—	—	—	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 6 to \<12 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=13 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=8 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=9 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 n=8 Participants Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
CL/F of Aprepitant in Participants 6 to <12 Years of Age	42.1 mL/min Standard Deviation 12.7	69.2 mL/min Standard Deviation 66.4	78.8 mL/min Standard Deviation 39.1	89.6 mL/min Standard Deviation 40.9	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Cmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=12 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=12 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=13 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Cmax of Aprepitant in Participants 12 to 17 Years of Age	3500 ng/mL Standard Deviation 972	1180 ng/mL Standard Deviation 408	582 ng/mL Standard Deviation 437	—	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The Tmax for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=12 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=12 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=13 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Tmax of Aprepitant in Participants 12 to 17 Years of Age	0.546 hours Standard Deviation 0.144	0.722 hours Standard Deviation 0.608	0.736 hours Standard Deviation 0.561	—	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-∞ for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=3 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=8 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=9 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
AUC 0-∞ of Aprepitant in Participants 12 to 17 Years of Age	33800 hr•ng/mL Standard Deviation 7180	12300 hr•ng/mL Standard Deviation 4660	3500 hr•ng/mL Standard Deviation 1430	—	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The AUC 0-24hr for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=12 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=12 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=13 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
AUC 0-24hr of Aprepitant in Participants 12 to 17 Years of Age	30400 hr•ng/mL Standard Deviation 8290	9700 hr•ng/mL Standard Deviation 4200	4820 hr•ng/mL Standard Deviation 7240	—	—

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The t1/2 for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=3 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=8 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=9 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
t1/2 of Aprepitant in Participants 12 to 17 Years of Age Hours	10.5 hours Standard Deviation 1.00	7.92 hours Standard Deviation 1.38	8.27 hours Standard Deviation 1.20	—	—

PRIMARY outcome

Timeframe: Approximately 24 hours (from 23 to 25 hours) post-infusion

Population: All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C24hr for aprepitant was determined by measuring aprepitant levels in the time frame of 23 to 25 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=12 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=12 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=13 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
C24hr of Aprepitant in Participants 12 to 17 Years of Age	735 ng/mL Standard Deviation 310	142 ng/mL Standard Deviation 86.4	101 ng/mL Standard Deviation 247	—	—

PRIMARY outcome

Timeframe: Approximately 48 hours (from 46 to 50 hours) post-infusion

Population: All participants 12 to 17 years of age that received at least one 5 mg/mL dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The C48hr for aprepitant was determined by measuring aprepitant levels in the time frame of 46 to 50 hours post-infusion. The C48hr was only planned to be measured in the 5 mg/mL dose for each age group.

Outcome measures

Outcome data not reported

PRIMARY outcome

Timeframe: Pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion

Population: All participants 12 to 17 years of age that received one dose of study therapy, did not have important deviations from the study protocol, and had data that contributed to the outcome being measured.

Fosaprepitant is a pro-drug that is rapidly converted to aprepitant. Because of this rapid conversion to aprepitant, fosaprepitant cannot be assessed directly. The pharmacokinetics for each fosaprepitant dose were determined by analyzing aprepitant in plasma. The CL/F for aprepitant was determined by measuring aprepitant levels at pre-infusion, immediately after infusion, and 2-4, 5-7, 8-10, 23-25, and 46-50 hours post-infusion.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=3 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=8 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=9 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
CL/F of Aprepitant in Participants 12 to 17 Years of Age	76.2 mL/min Standard Deviation 16.2	91.7 mL/min Standard Deviation 32.5	105 mL/min Standard Deviation 29.0	—	—

PRIMARY outcome

Timeframe: Up to 14 days postdose in Cycle 1

Population: All randomized participants who received at least one dose of study treatment in Cycle 1.

AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=74 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=42 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 n=43 Participants Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 n=40 Participants Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 n=35 Participants Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycle 1	87.8 Percentage of participants	83.3 Percentage of participants	90.7 Percentage of participants	80.0 Percentage of participants	77.1 Percentage of participants

PRIMARY outcome

Timeframe: Up to 14 days postdose for each cycle (Cycles 2-6)

Population: All randomized participants who received at least one dose of study treatment in Cycles 2-6.

AE was defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which did not necessarily have to have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product/protocol specified procedure, whether or not considered related to the medicinal product/protocol specified procedure. Any worsening of a preexisting condition temporally associated with the use of the product was also an AE.

Outcome measures

Measure	Fosaprepitant 5 mg/kg: 0 to <2 Years-Cycle 1 n=44 Participants Participants were administered IV fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; and participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/kg: 2 to <6 Years-Cycle 1 n=80 Participants Participants were administered a weight-adjusted dose of 3 mg/kg fosaprepitant IV (not to exceed 150 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 1.2 mg/kg of fosaprepitant IV (not to exceed 60 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 0.4 mg/kg: 2 to <6 Years-Cycle 1 Participants were administered a weight-adjusted dose of 0.4 mg/kg fosaprepitant IV (not to exceed 20 mg). Participants were also administered IV ondansetron at 0.15 mg/kg x 3 doses with or without dexamethasone.	Placebo Control-Cycle 1 Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.
Percentage of Participants Who Experienced at Least One Adverse Event (AE) in Cycles 2-6	93.6 Percentage of participants	75.5 Percentage of participants	—	—	—

Adverse Events

Fosaprepitant 0.4 mg/Kg-Cycle 1

Serious events: 11 serious events

Other events: 27 other events

Deaths: 0 deaths

Fosaprepitant 1.2 mg/Kg-Cycle 1

Serious events: 14 serious events

Other events: 33 other events

Deaths: 0 deaths

Fosaprepitant 3 mg/Kg-Cycle 1

Serious events: 12 serious events

Other events: 32 other events

Deaths: 0 deaths

Fosaprepitant 5 mg/Kg-Cycle 1

Serious events: 24 serious events

Other events: 60 other events

Deaths: 0 deaths

Placebo Control-Cycle 1

Serious events: 12 serious events

Other events: 24 other events

Deaths: 0 deaths

Fosaprepitant 3 mg/Kg-Cycles 2-6

Serious events: 46 serious events

Other events: 69 other events

Deaths: 0 deaths

Fosaprepitant 5 mg/Kg-Cycles 2-6

Serious events: 24 serious events

Other events: 31 other events

Deaths: 0 deaths

Serious adverse events

Measure	Fosaprepitant 0.4 mg/Kg-Cycle 1 n=40 participants at risk Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/Kg-Cycle 1 n=43 participants at risk Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 3 mg/Kg-Cycle 1 n=42 participants at risk Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 5 mg/Kg-Cycle 1 n=74 participants at risk Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Placebo Control-Cycle 1 n=35 participants at risk Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/Kg-Cycles 2-6 n=106 participants at risk For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.	Fosaprepitant 5 mg/Kg-Cycles 2-6 n=47 participants at risk For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.
Blood and lymphatic system disorders Anaemia	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.9% 1/35 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	1.9% 2/106 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Blood and lymphatic system disorders Febrile neutropenia	17.5% 7/40 • Number of events 7 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	23.3% 10/43 • Number of events 10 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	16.7% 7/42 • Number of events 8 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	17.6% 13/74 • Number of events 13 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	11.4% 4/35 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	24.5% 26/106 • Number of events 47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	38.3% 18/47 • Number of events 32 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Blood and lymphatic system disorders Leukopenia	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.3% 1/43 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.4% 1/42 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.9% 1/35 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	3.8% 4/106 • Number of events 9 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.1% 1/47 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Blood and lymphatic system disorders Neutropenia	2.5% 1/40 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.3% 1/43 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.9% 1/35 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	6.6% 7/106 • Number of events 13 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Blood and lymphatic system disorders Pancytopenia	2.5% 1/40 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Blood and lymphatic system disorders Thrombocytopaenia	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	1.9% 2/106 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Gastrointestinal disorders Abdominal pain	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.3% 1/43 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Gastrointestinal disorders Diarrhoea	2.5% 1/40 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Gastrointestinal disorders Stomatitis	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.7% 2/43 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.4% 1/42 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.9% 1/35 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.8% 3/106 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Gastrointestinal disorders Vomiting	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	1.4% 1/74 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	3.8% 4/106 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Gastrointestinal disorders Proctalgia	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
General disorders Asthenia	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.3% 1/43 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
General disorders Mucosal inflammation	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.7% 2/74 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.8% 3/106 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
General disorders Pyrexia	2.5% 1/40 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	1.4% 1/74 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.9% 1/35 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.3% 2/47 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Immune system disorders Anaphylactic reaction	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	1.4% 1/74 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Gastroenteritis norovirus	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	1.4% 1/74 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Herpes virus infection	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.4% 1/42 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Infection	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.9% 1/35 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Neutropenic sepsis	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.8% 2/42 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Sepsis	2.5% 1/40 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Septic shock	2.5% 1/40 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Skin infection	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.9% 1/35 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Tooth infection	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	1.4% 1/74 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Bacteraemia	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Cellulitis	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Cytomegalovirus infection	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.1% 1/47 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Device related infection	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	3.8% 4/106 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Febrile infection	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Gastroenteritis	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	1.9% 2/106 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Herpes simplex	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Herpes zoster	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Postoperative wound infection	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Pyelonephritis acute	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.1% 1/47 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Respiratory tract infection	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Tonsillitis	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.1% 1/47 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Urinary tract infection	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Infections and infestations Viral infection	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.3% 2/47 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Investigations Blood magnesium decreased	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.3% 1/43 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Investigations Blood phosphorous decreased	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.3% 1/43 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Investigations C-reactive protein increased	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.4% 1/42 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Investigations Neutrophil count decreased	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.7% 2/74 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	5.7% 2/35 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Investigations White blood cell count decreased	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.9% 1/35 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Investigations Drug level increased	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Metabolism and nutrition disorders Decreased appetitie	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.7% 2/74 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Metabolism and nutrition disorders Hypokalaemia	2.5% 1/40 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Metabolism and nutrition disorders Dehydration	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Nervous system disorders Hydrocephalus	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	1.4% 1/74 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.1% 1/47 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Nervous system disorders Seizure	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.7% 2/74 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.1% 1/47 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Nervous system disorders Febrile convulsion	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.1% 1/47 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Nervous system disorders Neuropathy peripheral	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Nervous system disorders Neurotoxicity	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Product Issues Device breakage	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Renal and urinary disorders Cystitis haemorrhagic	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.3% 1/43 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.1% 1/47 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Renal and urinary disorders Renal impairment	2.5% 1/40 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Respiratory, thoracic and mediastinal disorders Asthma	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	1.4% 1/74 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/106 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Vascular disorders air embolism	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.94% 1/106 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.

Other adverse events

Measure	Fosaprepitant 0.4 mg/Kg-Cycle 1 n=40 participants at risk Participants 12 to 17 years old were administered 20 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 0.4 mg/kg (not to exceed 20 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 1.2 mg/Kg-Cycle 1 n=43 participants at risk Participants 12 to 17 years old were administered 60 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 1.2 mg/kg (not to exceed 60 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 3 mg/Kg-Cycle 1 n=42 participants at risk Participants 12 to 17 years old were administered 150 mg IV fosaprepitant. Participants 2 to \<12 years old were administered a weight-adjusted dose of 3 mg/kg (not to exceed 150 mg). Participants were also administered IV ondansetron 0.15 mg/kg x 3 doses with or without dexamethasone.	Fosaprepitant 5 mg/Kg-Cycle 1 n=74 participants at risk Participants were administered intravenous (IV) fosaprepitant at the following weight-adjusted doses: participants 4 months to \<12 years old were administered 5 mg/kg (not to exceed 150 mg); participants 1 to \<4 months old were administered 2.5 mg/kg; participants 0 to \<1 month old were administered 1.25 mg/kg. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Placebo Control-Cycle 1 n=35 participants at risk Participants were administered IV normal saline at volume to match age and weight specific doses of fosaprepitant. Participants were also administered IV ondansetron (0.15 mg/kg x 3 doses for children 6 months to 17 years of age or per local standard of care for children \<6 months of age), with or without dexamethasone.	Fosaprepitant 3 mg/Kg-Cycles 2-6 n=106 participants at risk For optional Cycles 2-6, participants from Cycle 1 fosaprepitant arms (3, 1.2, or 0.4 mg/kg) or Cycle 1 control arm were administered fosaprepitant 3 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5-HT3 antagonist with or without dexamethasone.	Fosaprepitant 5 mg/Kg-Cycles 2-6 n=47 participants at risk For optional Cycles 2-6, participants from the 5 mg/kg fosaprepitant arm in Cycle 1 were administered fosaprepitant 5 mg/kg IV (or age-adjusted equivalent). For Cycle 2, fosaprepitant was administered IV plus ondansetron with or without dexamethasone. For Cycles 3-6, fosaprepitant was administered IV plus a 5- hydroxytryptamine 3 (5-HT3) antagonist with or without dexamethasone. Participants 1 year or less were required to receive ondansetron in all cycles as the 5-HT3 antagonist.
Blood and lymphatic system disorders Anaemia	22.5% 9/40 • Number of events 10 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	25.6% 11/43 • Number of events 12 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	28.6% 12/42 • Number of events 12 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	36.5% 27/74 • Number of events 28 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	28.6% 10/35 • Number of events 10 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	31.1% 33/106 • Number of events 54 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	29.8% 14/47 • Number of events 18 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Blood and lymphatic system disorders Leukopenia	10.0% 4/40 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	7.0% 3/43 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	14.3% 6/42 • Number of events 6 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	6.8% 5/74 • Number of events 8 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	11.4% 4/35 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	9.4% 10/106 • Number of events 22 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	12.8% 6/47 • Number of events 16 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Blood and lymphatic system disorders Neutropenia	17.5% 7/40 • Number of events 7 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	23.3% 10/43 • Number of events 10 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	21.4% 9/42 • Number of events 10 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	24.3% 18/74 • Number of events 19 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	22.9% 8/35 • Number of events 8 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	13.2% 14/106 • Number of events 19 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	8.5% 4/47 • Number of events 8 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Blood and lymphatic system disorders Thrombocytopenia	22.5% 9/40 • Number of events 9 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	14.0% 6/43 • Number of events 7 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	26.2% 11/42 • Number of events 11 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	14.9% 11/74 • Number of events 11 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	25.7% 9/35 • Number of events 9 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	17.9% 19/106 • Number of events 44 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	21.3% 10/47 • Number of events 19 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/42 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.7% 2/74 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	1.9% 2/106 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	8.5% 4/47 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Gastrointestinal disorders Abdominal pain	15.0% 6/40 • Number of events 11 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	9.3% 4/43 • Number of events 6 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	14.3% 6/42 • Number of events 6 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	6.8% 5/74 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	11.4% 4/35 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	17.9% 19/106 • Number of events 30 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.1% 1/47 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Gastrointestinal disorders Constipation	7.5% 3/40 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.7% 2/43 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	9.5% 4/42 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	12.2% 9/74 • Number of events 9 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	11.4% 4/35 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	8.5% 9/106 • Number of events 9 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.3% 2/47 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Gastrointestinal disorders Diarrhoea	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	7.0% 3/43 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.8% 2/42 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	8.1% 6/74 • Number of events 6 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.9% 1/35 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	9.4% 10/106 • Number of events 10 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	8.5% 4/47 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Gastrointestinal disorders Nausea	15.0% 6/40 • Number of events 7 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	7.0% 3/43 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	9.5% 4/42 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	10.8% 8/74 • Number of events 21 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	5.7% 2/35 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	21.7% 23/106 • Number of events 40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	12.8% 6/47 • Number of events 8 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Gastrointestinal disorders Proctalgia	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.4% 1/42 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/74 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	5.7% 2/35 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	1.9% 2/106 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.1% 1/47 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Gastrointestinal disorders Stomatitis	5.0% 2/40 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.7% 2/43 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.8% 2/42 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.7% 2/74 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	5.7% 2/35 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	7.5% 8/106 • Number of events 8 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	6.4% 3/47 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Gastrointestinal disorders Vomiting	22.5% 9/40 • Number of events 9 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	11.6% 5/43 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	16.7% 7/42 • Number of events 8 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	18.9% 14/74 • Number of events 20 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	8.6% 3/35 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	28.3% 30/106 • Number of events 69 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	25.5% 12/47 • Number of events 17 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
General disorders Mucosal inflammation	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	11.6% 5/43 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.8% 2/42 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.7% 2/74 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	5.7% 6/106 • Number of events 9 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.3% 2/47 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
General disorders Pyrexia	5.0% 2/40 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	7.0% 3/43 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	11.9% 5/42 • Number of events 6 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	10.8% 8/74 • Number of events 8 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	8.6% 3/35 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	12.3% 13/106 • Number of events 19 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	8.5% 4/47 • Number of events 8 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Investigations Alanine aminotransferase increased	10.0% 4/40 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.7% 2/43 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.4% 1/42 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	8.1% 6/74 • Number of events 6 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	5.7% 2/35 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	14.2% 15/106 • Number of events 22 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.3% 2/47 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Investigations Aspartate aminotransferase increased	7.5% 3/40 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.7% 2/43 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.8% 2/42 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	10.8% 8/74 • Number of events 8 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	5.7% 2/35 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	12.3% 13/106 • Number of events 21 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	8.5% 4/47 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Investigations Neutrophil count decreased	7.5% 3/40 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	11.6% 5/43 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.8% 2/42 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	14.9% 11/74 • Number of events 11 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	5.7% 2/35 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	14.2% 15/106 • Number of events 38 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	23.4% 11/47 • Number of events 17 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Investigations Platelet count decreased	7.5% 3/40 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	16.3% 7/43 • Number of events 8 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	11.9% 5/42 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	21.6% 16/74 • Number of events 16 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	8.6% 3/35 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	14.2% 15/106 • Number of events 37 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	10.6% 5/47 • Number of events 8 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Investigations White blood cell count decreased	12.5% 5/40 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	7.0% 3/43 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.8% 2/42 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	6.8% 5/74 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	8.6% 3/35 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	12.3% 13/106 • Number of events 23 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	10.6% 5/47 • Number of events 6 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Investigations C-reactive protein increased	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.8% 2/42 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.7% 2/74 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.9% 1/35 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.7% 5/106 • Number of events 8 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	6.4% 3/47 • Number of events 7 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Metabolism and nutrition disorders Decreased appetite	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	9.5% 4/42 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	6.8% 5/74 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	8.6% 3/35 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	1.9% 2/106 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.3% 2/47 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/43 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	7.1% 3/42 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	1.4% 1/74 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/35 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	3.8% 4/106 • Number of events 6 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.1% 1/47 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	7.0% 3/43 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	9.5% 4/42 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.7% 2/74 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	5.7% 2/35 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	14.2% 15/106 • Number of events 25 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.3% 2/47 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Metabolism and nutrition disorders Hypophosphataemia	0.00% 0/40 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.3% 1/43 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	7.1% 3/42 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	5.4% 4/74 • Number of events 4 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.9% 1/35 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	8.5% 9/106 • Number of events 18 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.3% 2/47 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Nervous system disorders Headache	7.5% 3/40 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	14.0% 6/43 • Number of events 9 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	9.5% 4/42 • Number of events 7 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.7% 2/74 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	5.7% 2/35 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	10.4% 11/106 • Number of events 15 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.3% 2/47 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Respiratory, thoracic and mediastinal disorders Cough	2.5% 1/40 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.7% 2/43 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.4% 1/42 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	8.1% 6/74 • Number of events 6 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.9% 1/35 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	11.3% 12/106 • Number of events 13 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.1% 1/47 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.
Respiratory, thoracic and mediastinal disorders Hiccups	5.0% 2/40 • Number of events 10 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	7.0% 3/43 • Number of events 5 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	4.8% 2/42 • Number of events 2 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	1.4% 1/74 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.9% 1/35 • Number of events 1 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	2.8% 3/106 • Number of events 3 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.	0.00% 0/47 • Up to 14 days after the dose of study drug for Cycles 1-6 (approximately up to 84 days total) AEs were reported for the All Patients as Treated Population that included all randomized participants who received at least one dose of study treatment. All AEs (serious and non-serious) were reported in Cycle 1. In Cycles 2-6, only serious AEs and non-serious AEs that were either drug-related AEs or led to discontinuation were reported. The participants who completed Cycle 1 (base study) were invited to participate in optional Cycles 2-6; there were no new participants enrolled.

Additional Information

Senior Vice President, Global Clinical Development

Merck Sharp & Dohme Corp.

Phone: 1-800-672-6372

Email: ClinicalTrialsDisclosure@merck.com

Results disclosure agreements

• Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts, or presentations regarding this study 60 days prior to submission for publication/presentation. Any information identified by the Sponsor as confidential must be deleted prior to submission. Sponsor review can be expedited to meet publication guidelines.
• Publication restrictions are in place

Restriction type: OTHER