Trial Outcomes & Findings for Durvalumab and Tremelimumab for Pediatric Malignancies (NCT NCT03837899)

Last Updated: 2024-10-29

Results Overview

Serum samples were collected from the participants at the defined timepoints. Cmax was determined using standard non-compartmental methods.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE1/PHASE2

Target enrollment

50 participants

Primary outcome timeframe

Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 6, 8, 10 and 12

Results posted on

2024-10-29

Participant Flow

This open-label study was conducted in 2 sequential phases: a dose-finding phase (Phase I), followed by a dose-expansion phase (Phase II) in pediatric participants with advanced solid tumors, including sarcoma. Here, results for data analyzed through data cut-off date (DCO) 20-Apr-2023 have been reported.

Each treatment cycle was 28 days. Overall, 33 participants were enrolled in dose-finding phase and 29 participants were administered study treatment. In dose-expansion phase, 23 participants were enrolled and 21 participants were administered study treatment.

Participant milestones

Participant milestones
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \>= 35 kilograms (kg) were administered durvalumab 20 milligram (mg)/kg intravenously (IV) in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Overall Study STARTED	7	11	3	8	11	10
Overall Study COMPLETED	1	0	0	0	0	0
Overall Study NOT COMPLETED	6	11	3	8	11	10

Reasons for withdrawal

Reasons for withdrawal
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \>= 35 kilograms (kg) were administered durvalumab 20 milligram (mg)/kg intravenously (IV) in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Overall Study Death	6	8	3	7	8	7
Overall Study Moved to post-trial access program	0	1	0	0	0	0
Overall Study Other	0	0	0	0	0	2
Overall Study Lost to Follow-up	0	1	0	0	0	0
Overall Study Withdrawal by Subject	0	0	0	1	0	0
Overall Study Study specific discontinuation criteria	0	1	0	0	3	1

Baseline Characteristics

Durvalumab and Tremelimumab for Pediatric Malignancies

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=7 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.	Total n=50 Participants Total of all reporting groups
Age, Customized In utero	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized Preterm newborn infants (gestational age < 37 weeks)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized Newborns (0-27 days)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized Infants and toddlers (28 days-23 months)	1 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Age, Customized Children (2-11 years)	0 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	6 Participants n=4 Participants	7 Participants n=21 Participants	3 Participants n=8 Participants	24 Participants n=8 Participants
Age, Customized Adolescents (12-17 years)	6 Participants n=5 Participants	6 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants	4 Participants n=21 Participants	7 Participants n=8 Participants	25 Participants n=8 Participants
Age, Customized Adults (18-64 years)	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized From 65-84 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Age, Customized 85 years and above	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	8 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	6 Participants n=21 Participants	5 Participants n=8 Participants	26 Participants n=8 Participants
Sex: Female, Male Male	4 Participants n=5 Participants	3 Participants n=7 Participants	2 Participants n=5 Participants	5 Participants n=4 Participants	5 Participants n=21 Participants	5 Participants n=8 Participants	24 Participants n=8 Participants
Race/Ethnicity, Customized Black or African American	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants	0 Participants n=8 Participants	0 Participants n=8 Participants
Race/Ethnicity, Customized American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	0 Participants n=8 Participants	1 Participants n=8 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	1 Participants n=21 Participants	1 Participants n=8 Participants	3 Participants n=8 Participants
Race/Ethnicity, Customized White	5 Participants n=5 Participants	8 Participants n=7 Participants	2 Participants n=5 Participants	4 Participants n=4 Participants	8 Participants n=21 Participants	6 Participants n=8 Participants	33 Participants n=8 Participants
Race/Ethnicity, Customized Other	1 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	3 Participants n=4 Participants	1 Participants n=21 Participants	3 Participants n=8 Participants	10 Participants n=8 Participants
Race/Ethnicity, Customized Hispanic or Latino	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants	0 Participants n=21 Participants	2 Participants n=8 Participants	7 Participants n=8 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	6 Participants n=5 Participants	9 Participants n=7 Participants	2 Participants n=5 Participants	7 Participants n=4 Participants	11 Participants n=21 Participants	8 Participants n=8 Participants	43 Participants n=8 Participants

PRIMARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 6, 8, 10 and 12

Population: The pharmacokinetic (PK) analysis set included all participants who received at least 1 dose of study treatment per the clinical study protocol (CSP) for whom any post-dose data were available who did not violate or deviate from the CSP in ways that would significantly affect the PK analysis.

Serum samples were collected from the participants at the defined timepoints. Cmax was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=7 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: Maximum Serum Concentration (Cmax) of Durvalumab	363 micrograms/ milliliter (mcg/mL) Geometric Coefficient of Variation 58.0	865 micrograms/ milliliter (mcg/mL) Geometric Coefficient of Variation 36.0	275 micrograms/ milliliter (mcg/mL) Geometric Coefficient of Variation 135	612 micrograms/ milliliter (mcg/mL) Geometric Coefficient of Variation 34.2	—	—

PRIMARY outcome

Population: The PK analysis set included all participants who received at least 1 dose of study treatment per the CSP for whom any post-dose data were available who did not violate or deviate from the CSP in ways that would significantly affect the PK analysis. Only data from the participants analyzed were reported.

Serum samples were collected from the participants at the defined timepoints. Cmin was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=6 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=4 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: Minimum Serum Concentration (Cmin) of Durvalumab	48.6 mcg/mL Geometric Coefficient of Variation 104	169 mcg/mL Geometric Coefficient of Variation 28.5	21.7 mcg/mL Geometric Coefficient of Variation 34.6	118 mcg/mL Geometric Coefficient of Variation 45.4	—	—

PRIMARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8

Serum samples were collected from the participants at the defined timepoints. AUC (0-14) was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=7 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=9 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=6 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: Area Under the Serum Concentration-Time Curve (AUC) From Zero to 14 (AUC 0-14) of Durvalumab	2650 day*mcg/mL Geometric Coefficient of Variation 61.5	5660 day*mcg/mL Geometric Coefficient of Variation 17.7	1830 day*mcg/mL Geometric Coefficient of Variation 54.7	3720 day*mcg/mL Geometric Coefficient of Variation 46.9	—	—

PRIMARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15

Serum samples were collected from the participants at the defined timepoints. AUC (0-28) was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=6 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=4 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: AUC From Zero to 28 (AUC 0-28) of Durvalumab	3290 day*mcg/mL Geometric Coefficient of Variation 50.1	8790 day*mcg/mL Geometric Coefficient of Variation 13.5	2500 day*mcg/mL Geometric Coefficient of Variation 55.4	6380 day*mcg/mL Geometric Coefficient of Variation 40.1	—	—

PRIMARY outcome

Serum samples were collected from the participants at the defined timepoints. Tmax was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=7 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: Time to Cmax (Tmax) of Durvalumab	0.094 days Interval 0.09 to 0.1	0.087 days Interval 0.0 to 0.14	0.09 days Interval 0.09 to 6.94	0.087 days Interval 0.08 to 0.09	—	—

PRIMARY outcome

Serum samples were collected from the participants at the defined timepoints. T½λz was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=6 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=6 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=1 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=2 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: Apparent Terminal Elimination Half-life Associated With the Terminal Slope of the Semi-logarithmic Concentration Time Curve (t½λz) of Durvalumab	16.7 days Geometric Coefficient of Variation 47.1	25.3 days Geometric Coefficient of Variation 56.5	8.26 days Geometric Coefficient of Variation NA NA indicates geometric coefficient of variation was not calculated for 1 participant.	15.6 days Geometric Coefficient of Variation 23.3	—	—

PRIMARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8

Serum samples were collected from the participants at the defined timepoints. AUC(0-14)/D was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=7 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=9 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=6 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: Dose-Normalized AUC (0-14) (AUC [0-14]/D) of Durvalumab	132 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 61.5	189 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 17.7	91.6 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 54.7	124 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 46.9	—	—

PRIMARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15

Serum samples were collected from the participants at the defined timepoints. AUC(0-28)/D was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=6 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=4 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: Dose-Normalized AUC (0-28) (AUC [0-28]/D) of Durvalumab	164 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 50.1	293 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 13.5	125 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 55.4	213 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 40.1	—	—

PRIMARY outcome

Serum samples were collected from the participants at the defined timepoints. Cmax/D was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=7 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: Dose-Normalized Cmax (Cmax/D) of Durvalumab	18.1 (mcg/mL)/(mg/kg) Geometric Coefficient of Variation 58.0	28.8 (mcg/mL)/(mg/kg) Geometric Coefficient of Variation 36.0	13.7 (mcg/mL)/(mg/kg) Geometric Coefficient of Variation 135	20.4 (mcg/mL)/(mg/kg) Geometric Coefficient of Variation 34.2	—	—

PRIMARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5

Serum samples were collected from the participants at the defined timepoints. Cmax was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=6 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=4 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: Cmax of Tremelimumab	19.1 mcg/mL Geometric Coefficient of Variation 73.3	24.5 mcg/mL Geometric Coefficient of Variation 44.7	39.2 mcg/mL Geometric Coefficient of Variation 68.8	23.0 mcg/mL Geometric Coefficient of Variation 31.7	—	—

PRIMARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5

Serum samples were collected from the participants at the defined timepoints. Cmin was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=2 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=4 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: Cmin of Tremelimumab	3.71 mcg/mL Geometric Coefficient of Variation 3.75	3.45 mcg/mL Geometric Coefficient of Variation 29.2	—	3.03 mcg/mL Geometric Coefficient of Variation 50.3	—	—

PRIMARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 2 Day 1, and Cycle 2 Day 8

Serum samples were collected from the participants at the defined timepoints. AUC (0-14) was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=5 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=7 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=2 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=4 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: (AUC 0-14) of Tremelimumab	127 day*mcg/mL Geometric Coefficient of Variation 47.3	160 day*mcg/mL Geometric Coefficient of Variation 35.6	165 day*mcg/mL Geometric Coefficient of Variation 7.00	149 day*mcg/mL Geometric Coefficient of Variation 20.1	—	—

PRIMARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, and Cycle 2 Day 15

Serum samples were collected from the participants at the defined timepoints. AUC (0-28) was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=2 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=4 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: (AUC 0-28) of Tremelimumab	235 day*mcg/mL Geometric Coefficient of Variation 11.2	205 day*mcg/mL Geometric Coefficient of Variation 22.9	—	208 day*mcg/mL Geometric Coefficient of Variation 14.8	—	—

PRIMARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5

Serum samples were collected from the participants at the defined timepoints. Tmax was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=6 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=4 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: Tmax of Tremelimumab	0.046 days Interval 0.04 to 0.08	0.051 days Interval 0.04 to 0.07	0.040 days Interval 0.04 to 0.05	0.046 days Interval 0.04 to 0.18	—	—

PRIMARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5

Serum samples were collected from the participants at the defined timepoints. T½λz was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=2 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=2 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: T½λz of Tremelimumab	16.8 days Geometric Coefficient of Variation 5.27	18.7 days Geometric Coefficient of Variation 20.5	—	31.6 days Geometric Coefficient of Variation 86.0	—	—

PRIMARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 2 Day 1 and Cycle 2 Day 8

Serum samples were collected from the participants at the defined timepoints. AUC(0-14)/D was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=5 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=7 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=2 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=4 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: AUC (0-14)/D of Tremelimumab	127 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 47.3	160 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 35.6	165 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 7.00	149 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 20.1	—	—

PRIMARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, and Cycle 2 Day 15

Serum samples were collected from the participants at the defined timepoints. AUC(0-28)/D was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=2 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=4 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: AUC (0-28)/D of Tremelimumab	235 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 11.2	205 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 22.9	—	208 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 14.8	—	—

PRIMARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 2 Day 8, Cycle 2 Day 15, pre-infusion and post-infusion in Cycle 3, 4, and 5

Serum samples were collected from the participants at the defined timepoints. Cmax/D was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=6 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=4 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: Cmax/D of Tremelimumab	19.1 (mcg/mL)/(mg/kg) Geometric Coefficient of Variation 73.3	24.5 (mcg/mL)/(mg/kg) Geometric Coefficient of Variation 44.7	39.2 (mcg/mL)/(mg/kg) Geometric Coefficient of Variation 68.8	23.0 (mcg/mL)/(mg/kg) Geometric Coefficient of Variation 31.7	—	—

PRIMARY outcome

Timeframe: From Day 1 up to 15 months

Population: The Safety analysis set included all participants who received any amount of study treatment.

An AE was defined as any untoward medical occurrence in a participant temporally associated with the use of study treatment, whether or not considered related to the study treatment. SAEs were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. Some AEs and higher-level terms were considered AESI or AEPIs and this list of categories were provided by the patient safety team.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=7 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: Number of Participants With Adverse Events (AE), Serious AE (SAE), AE Leading to Discontinuation of Durvalumab and Tremelimumab, AE of Special Interest (AESI) or AE of Possible Interest (AEPI) Related to Durvalumab and Tremelimumab Any AE	6 Participants	11 Participants	3 Participants	7 Participants	—	—
Dose-Finding Phase: Number of Participants With Adverse Events (AE), Serious AE (SAE), AE Leading to Discontinuation of Durvalumab and Tremelimumab, AE of Special Interest (AESI) or AE of Possible Interest (AEPI) Related to Durvalumab and Tremelimumab Any SAE	1 Participants	1 Participants	0 Participants	1 Participants	—	—
Dose-Finding Phase: Number of Participants With Adverse Events (AE), Serious AE (SAE), AE Leading to Discontinuation of Durvalumab and Tremelimumab, AE of Special Interest (AESI) or AE of Possible Interest (AEPI) Related to Durvalumab and Tremelimumab AE leading to discontinuation of Durvalumab	0 Participants	0 Participants	0 Participants	0 Participants	—	—
Dose-Finding Phase: Number of Participants With Adverse Events (AE), Serious AE (SAE), AE Leading to Discontinuation of Durvalumab and Tremelimumab, AE of Special Interest (AESI) or AE of Possible Interest (AEPI) Related to Durvalumab and Tremelimumab AE leading to discontinuation of Tremelimumab	0 Participants	1 Participants	0 Participants	0 Participants	—	—
Dose-Finding Phase: Number of Participants With Adverse Events (AE), Serious AE (SAE), AE Leading to Discontinuation of Durvalumab and Tremelimumab, AE of Special Interest (AESI) or AE of Possible Interest (AEPI) Related to Durvalumab and Tremelimumab AESIs or AEPIs related to Durvalumab	1 Participants	4 Participants	0 Participants	2 Participants	—	—
Dose-Finding Phase: Number of Participants With Adverse Events (AE), Serious AE (SAE), AE Leading to Discontinuation of Durvalumab and Tremelimumab, AE of Special Interest (AESI) or AE of Possible Interest (AEPI) Related to Durvalumab and Tremelimumab AESIs or AEPIs related to Tremelimumab	0 Participants	2 Participants	0 Participants	1 Participants	—	—

PRIMARY outcome

Timeframe: From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

Population: The evaluable for response analysis set is the subset of participants in the FAS who had measurable disease (as per RECIST 1.1) at baseline and had at least 1 follow-up scan measuring all required target lesions and had been followed for at least 3 cycles or measurable disease (as per RECIST 1.1) at baseline and progressed or died in the absence of a follow-up scan.

ORR as per RECIST 1.1 was defined as the percentage of participants with at least 1 investigator-assessed visit response of complete response (CR) or partial response (PR) that was subsequently confirmed on another scan not less than 4 weeks after visit observed response. CR was defined as disappearance of all target lesions (TLs), any pathological lymph nodes selected as TLs with reduction in short axis to \< 10 millimeter (mm). PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference to baseline sum of diameters as long as criteria for PD are not met.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=9 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase Only: Objective Response Rate (ORR)	0 percentage of participants	11.1 percentage of participants	—	—	—	—

PRIMARY outcome

Timeframe: From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

Duration of response was the time from the first documentation of CR/PR (which was subsequently confirmed) until the date of documented progression, or death which coincides with the progression free survival (PFS) endpoint. For participants who did not progress following a response, the DOR was censored during the PFS censoring time. It was calculated using Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=1 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase Only: Duration of Response (DOR)	—	10.8 months Interval 10.8 to 10.8	—	—	—	—

PRIMARY outcome

Timeframe: From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

Population: The FAS included all participants who were assigned to treatment and received at least 1 dose of study treatment.

BOR was calculated based on the overall visit responses from each RECIST 1.1 assessment. Categorization of BOR for solid tumors were based on RECIST 1.1 using the following response categories: CR, PR, stable disease (SD), progression of disease (PD), and not evaluable (NE). CR: disappearance of all TLs. Any pathological lymph nodes selected as TLs had a reduction in short axis to \<10 mm. PR: 30% decrease in the sum of diameters of TLs. SD: Neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increased to qualify for PD. PD: \>= 20 % increase in the sum of diameters to TLs and an increase of \>= 5 mm. NE: Only relevant if any of the TLs were not assessed or NE or had a lesion intervention at visit. Non-CR/Non-PD: Persistence of 1+ non-target lesion (s). Non-CR/non-PD was relevant to participants who did not have measurable disease at baseline.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase Only: Best Objective Response (BOR) CR	0 Participants	0 Participants	—	—	—	—
Dose-Expansion Phase Only: Best Objective Response (BOR) PR	0 Participants	1 Participants	—	—	—	—
Dose-Expansion Phase Only: Best Objective Response (BOR) Unconfirmed complete or partial response	0 Participants	0 Participants	—	—	—	—
Dose-Expansion Phase Only: Best Objective Response (BOR) SD >= 7 weeks	1 Participants	1 Participants	—	—	—	—
Dose-Expansion Phase Only: Best Objective Response (BOR) PD	9 Participants	7 Participants	—	—	—	—
Dose-Expansion Phase Only: Best Objective Response (BOR) Not evaluable	1 Participants	1 Participants	—	—	—	—

PRIMARY outcome

Timeframe: At 16 and 24 Weeks

Population: The FAS included all participants who were assigned to treatment and received at least 1 dose of study treatment. Only participants who achieved a BOR were included in the analysis.

DCR was defined as the percentage of participants who achieved a BOR of unconfirmed CR or PR, respectively, or who had SD. CR was defined as disappearance of all TLs, any pathological lymph nodes selected as TLs with reduction in short axis to \< 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of TLs, with reference to baseline sum of diameters as long as criteria for PD are not met. SD: Neither sufficient decrease in sum of diameters to qualify for PR nor sufficient increased to qualify for PD.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase Only: Disease Control Rate (DCR) Week 16	9.1 percentage of participants	10.0 percentage of participants	—	—	—	—
Dose-Expansion Phase Only: Disease Control Rate (DCR) Week 24	9.1 percentage of participants	10.0 percentage of participants	—	—	—	—

PRIMARY outcome

Timeframe: From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

Population: The FAS included all participants who were assigned to treatment and received at least 1 dose of study treatment.

PFS as per RECIST 1.1 was defined as the time from the date of first dose of study treatment until the date of objective disease progression or death by any cause in the absence of progression, regardless of whether the participant withdrew from study therapy or received another anti-cancer therapy prior to progression (date of PFS event or censoring - date of first dose + 1). Confidence interval was calculated using Kaplan-Meier technique.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase Only: PFS	1.7 months Interval 1.58 to 1.91	1.7 months Interval 0.89 to 2.76	—	—	—	—

PRIMARY outcome

Timeframe: From first dose of study treatment until death or up to approximately 4 years (clinical DCO of 20 Apr 2023)

Population: The FAS included all participants who were assigned to treatment and received at least 1 dose of study treatment.

OS was defined as the time from the date of first dose of study treatment until death due to any cause regardless of whether the patient withdraws from study treatment or received another anti-cancer therapy (i.e date of death or censoring - date of first dose + 1).

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase Only: Overall Survival (OS)	6.6 months Interval 2.2 to 15.8	6.9 months Interval 3.2 to NA indicates higher inter-quartile range not reached.	—	—	—	—

PRIMARY outcome

Timeframe: At 12 and 24 Weeks

Population: The FAS included all participants who were assigned to treatment and received at least 1 dose of study treatment.

Survival rates were defined as the Kaplan-Meier estimate of OS at 12 and 24 months.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase Only: Survival Rate at 12 Months and 24 Months 12 Months	25.6 percentage of participants Interval 6.27 to 51.1	40.0 percentage of participants Interval 15.94 to 63.31	—	—	—	—
Dose-Expansion Phase Only: Survival Rate at 12 Months and 24 Months 24 Months	NA percentage of participants NA indicated survival rate not reached for 24 months at this DCO.	30.0 percentage of participants Interval 9.74 to 53.67	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 8, and 12

Serum samples were collected from the participants at the defined timepoints. Cmax was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: Cmax of Durvalumab	606 mcg/mL Geometric Coefficient of Variation 27.7	595 mcg/mL Geometric Coefficient of Variation 14.2	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 8, and 12

Serum samples were collected from the participants at the defined timepoints. Cmin was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=9 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=5 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: Cmin of Durvalumab	108 mcg/mL Geometric Coefficient of Variation 29.6	78.3 mcg/mL Geometric Coefficient of Variation 94.1	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8

Serum samples were collected from the participants at the defined timepoints. AUC (0-14) was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=9 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: AUC (0-14) of Durvalumab	4240 day*mcg/mL Geometric Coefficient of Variation 23.2	3900 day*mcg/mL Geometric Coefficient of Variation 20.0	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15

Serum samples were collected from the participants at the defined timepoints. AUC (0-28) was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=9 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=5 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: AUC (0-28) of Durvalumab	6400 day*mcg/mL Geometric Coefficient of Variation 23.7	5880 day*mcg/mL Geometric Coefficient of Variation 25.2	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 8, and 12

Serum samples were collected from the participants at the defined timepoints. Tmax was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: Tmax of Durvalumab	0.049 days Interval 0.04 to 0.09	0.051 days Interval 0.04 to 0.08	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 8, and 12

Serum samples were collected from the participants at the defined timepoints. T½λz was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=8 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=5 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: T½λz of Durvalumab	17.4 days Geometric Coefficient of Variation 26.2	14.2 days Geometric Coefficient of Variation 48.6	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8

Serum samples were collected from the participants at the defined timepoints. AUC (0-14)/D was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=9 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: AUC (0-14)/D of Durvalumab	141 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 23.2	130 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 20.0	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15

Serum samples were collected from the participants at the defined timepoints. AUC (0-28)/D was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=9 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=5 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: AUC (0-28)/D of Durvalumab	213 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 23.7	196 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 25.2	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, pre-infusion and post-infusion in Cycle 3, 4, 8, and 12

Serum samples were collected from the participants at the defined timepoints. Cmax/D was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: Cmax/D of Durvalumab	20.2 (mcg/mL)/(mg/kg) Geometric Coefficient of Variation 27.7	19.8 (mcg/mL)/(mg/kg) Geometric Coefficient of Variation 14.2	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 3 Day 1 pre-infusion and post-infusion on Cycle 4

Serum samples were collected from the participants at the defined timepoints. Cmax was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: Cmax of Tremelimumab	29.2 mcg/mL Geometric Coefficient of Variation 86.0	23.2 mcg/mL Geometric Coefficient of Variation 18.8	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 3 Day 1 pre-infusion and post-infusion on Cycle 4

Serum samples were collected from the participants at the defined timepoints. Cmin was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=9 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=6 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: Cmin of Tremelimumab	3.91 mcg/mL Geometric Coefficient of Variation 41.7	3.40 mcg/mL Geometric Coefficient of Variation 66.2	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8

Serum samples were collected from the participants at the defined timepoints. AUC (0-14) was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: AUC (0-14) of Tremelimumab	183 day*mcg/mL Geometric Coefficient of Variation 65.9	150 day*mcg/mL Geometric Coefficient of Variation 11.8	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15

Serum samples were collected from the participants at the defined timepoints. AUC (0-28) was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=9 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=6 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: AUC (0-28) of Tremelimumab	270 day*mcg/mL Geometric Coefficient of Variation 58.1	228 day*mcg/mL Geometric Coefficient of Variation 12.4	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 3 Day 1 pre-infusion and post-infusion on Cycle 4

Serum samples were collected from the participants at the defined timepoints. Tmax was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: Tmax of Tremelimumab	0.049 days Interval 0.04 to 0.06	0.052 days Interval 0.04 to 0.07	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 3 Day 1 pre-infusion and post-infusion on Cycle 4

Serum samples were collected from the participants at the defined timepoints. T½λz was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=7 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=6 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: T½λz of Tremelimumab	15.9 days Geometric Coefficient of Variation 26.2	15.6 days Geometric Coefficient of Variation 40.4	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1 and Cycle 1 Day 8

Serum samples were collected from the participants at the defined timepoints. AUC (0-14)/D was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: AUC (0-14)/D of Tremelimumab	183 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 65.9	150 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 11.8	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, and Cycle 1 Day 15

Serum samples were collected from the participants at the defined timepoints. AUC (0-28)/D was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=9 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=6 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: AUC (0-28)/D of Tremelimumab	270 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 58.1	228 (day*mcg/mL)/(mg/kg) Geometric Coefficient of Variation 12.4	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion and post-infusion on Cycle 1 Day 1, Cycle 1 Day 8, Cycle 1 Day 15, pre-infusion and post-infusion on Cycle 2 Day 1, Cycle 3 Day 1 pre-infusion and post-infusion on Cycle 4

Serum samples were collected from the participants at the defined timepoints. Cmax/D was determined using standard non-compartmental methods.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: Cmax/D of Tremelimumab	29.2 (mcg/mL)/(mg/kg) Geometric Coefficient of Variation 86.0	23.2 (mcg/mL)/(mg/kg) Geometric Coefficient of Variation 18.8	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion on Cycle 1 Day 1 and Cycle 3 Day 1 (durvalumab and tremelimumab), pre-infusion on Cycle 2 Day 1, Cycle 5 Day 1 and Cycle 8 Day 1 for tremelimumab

Population: The ADA analysis set included all participants who received at least 1 dose of study treatment per the CSP for whom baseline, and any post-dose data were available were included in the ADA analysis set. Only data from the participants analyzed were reported.

ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Persistently positive was defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. Transiently positive was defined as having at least 1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=4 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=1 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=1 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Finding Phase: Percentage of Participants Who Developed Detectable Anti-Drug Antibodies (ADAs) Durvalumab, ADA positive at any visit	25 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—
Dose-Finding Phase: Percentage of Participants Who Developed Detectable Anti-Drug Antibodies (ADAs) Durvalumab, Persistently positive	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—
Dose-Finding Phase: Percentage of Participants Who Developed Detectable Anti-Drug Antibodies (ADAs) Durvalumab, Transiently positive	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—
Dose-Finding Phase: Percentage of Participants Who Developed Detectable Anti-Drug Antibodies (ADAs) Tremelimumab, ADA positive at any visit	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—
Dose-Finding Phase: Percentage of Participants Who Developed Detectable Anti-Drug Antibodies (ADAs) Tremelimumab, Persistently positive	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—
Dose-Finding Phase: Percentage of Participants Who Developed Detectable Anti-Drug Antibodies (ADAs) Tremelimumab, Transiently positive	0 percentage of participants	0 percentage of participants	0 percentage of participants	0 percentage of participants	—	—

SECONDARY outcome

Timeframe: Pre-infusion on Cycle 1 Day 1 and Cycle 3 Day 1 (durvalumab and tremelimumab) and random sample on Cycle 7 Day 1 for tremelimumab

ADA prevalence was defined as the percentage of participants with positive ADA result at any time, baseline or post-baseline. Persistently positive was defined as having at least 2 post-baseline ADA positive measurements with at least 16 weeks (112 days) between the first and last positive measurements, or an ADA positive result at the last available assessment. The category includes participants meeting these criteria who are ADA positive at baseline. Transiently positive was defined as having at least 1 post-baseline ADA positive measurement and not fulfilling the conditions for persistently positive. The category includes participants meeting these criteria who are ADA positive at baseline.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=4 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=5 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Dose-Expansion Phase: Percentage of Participants Who Developed Detectable ADAs Durvalumab, Transiently positive	0 percentage of participants	0 percentage of participants	—	—	—	—
Dose-Expansion Phase: Percentage of Participants Who Developed Detectable ADAs Tremelimumab, Transiently positive	0 percentage of participants	0 percentage of participants	—	—	—	—
Dose-Expansion Phase: Percentage of Participants Who Developed Detectable ADAs Durvalumab, ADA positive at any visit	0 percentage of participants	20 percentage of participants	—	—	—	—
Dose-Expansion Phase: Percentage of Participants Who Developed Detectable ADAs Durvalumab, Persistently positive	0 percentage of participants	0 percentage of participants	—	—	—	—
Dose-Expansion Phase: Percentage of Participants Who Developed Detectable ADAs Tremelimumab, ADA positive at any visit	0 percentage of participants	0 percentage of participants	—	—	—	—
Dose-Expansion Phase: Percentage of Participants Who Developed Detectable ADAs Tremelimumab, Persistently positive	0 percentage of participants	0 percentage of participants	—	—	—	—

SECONDARY outcome

Timeframe: Pre-infusion on Cycle 1 Day 1 and Cycle 4 Day 1 for durvalumab, pre-infusion on Cycle 1 Day 1, pre-infusion on Cycle 3, 4, and 8 Day 1 for tremelimumab (dose-expansion)

Population: Participants who has a baseline titer collected and who has subsequent samples following a routine childhood immunization were included. As no participants received a routine immunization during the study, no additional samples were collected, hence no data analysed.

Blood samples were planned to be collected for vaccine antibody titer measurements before and after planned routine immunization.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=7 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 Participants Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=11 Participants Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=10 Participants Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Number of Participants With Individual Antibody Titer Measurement	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants	0 Participants

SECONDARY outcome

Timeframe: Pre-dose Cycle 1 Day 8, pre-dose Cycle 2 Day 1, Cycle 2 Day 8, pre-dose Cycle 3 Day 1 (Dose-finding); Pre-dose Cycle 1 Day 1, Cycle 1 Day 8, pre-dose Cycle 2 Day 1 (Dose-expansion)

Population: Participants who received the Durvalumab + tremelimumab combination who had a pre-treatment sample collected on Day 1 and a repeat sample on Day 8 were included. As the weight of the participant was not believed to impact the immune response, it was determined that aggregating the data by dosing regimen rather than by weight group, was considered acceptable for this particular analysis.

Blood samples were collected at indicated timepoints for flow cytometry assessment. Cycle (C) and Day (D). Data collected for the flow cytometry analysis from the participants enrolled in both the dose finding and dose expansion phase were analyzed in the context of the dosing regimen received, to determine any potential differences in the immune response based on the durvalumab dose.

Outcome measures

Outcome measures
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=12 Participants Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=7 Participants Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=7 Participants Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD4+ Ki67; C2D1	10.3 percentage of cells per cubic millimeter Interval -45.8 to 57.6	16.7 percentage of cells per cubic millimeter Interval -24.0 to 66.7	-25.8 percentage of cells per cubic millimeter Interval -43.8 to 37.8	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD4+ Ki67; C2D8	—	153.1 percentage of cells per cubic millimeter Interval 58.0 to 925.0	118.2 percentage of cells per cubic millimeter Interval 65.1 to 215.0	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD4+ Ki67; C3D1	—	-33.4 percentage of cells per cubic millimeter Interval -48.0 to -18.8	21.9 percentage of cells per cubic millimeter Interval -31.4 to 81.3	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD8+ Ki67; C1D8	20.0 percentage of cells per cubic millimeter Interval -25.0 to 88.9	—	—	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD8+ Ki67; C2D1	-20.0 percentage of cells per cubic millimeter Interval -70.8 to 117.5	133.3 percentage of cells per cubic millimeter Interval -9.9 to 431.3	-62.1 percentage of cells per cubic millimeter Interval -67.5 to 173.3	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD8+ Ki67; C3D1	—	0.0 percentage of cells per cubic millimeter Interval 0.0 to 0.0	-55.4 percentage of cells per cubic millimeter Interval -73.0 to 200.0	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD8+; C2D8	—	30.1 percentage of cells per cubic millimeter Interval -14.6 to 60.9	13.8 percentage of cells per cubic millimeter Interval -18.0 to 71.2	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 B cells; C2D1	6.2 percentage of cells per cubic millimeter Interval -3.1 to 56.9	27.2 percentage of cells per cubic millimeter Interval -1.5 to 650.0	-12.0 percentage of cells per cubic millimeter Interval -22.0 to 128.0	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 B cells; C2D8	—	20.6 percentage of cells per cubic millimeter Interval -4.8 to 1543.8	-8.2 percentage of cells per cubic millimeter Interval -26.2 to 43.1	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 B cells; C3D1	—	-2.5 percentage of cells per cubic millimeter Interval -8.6 to 3.6	15.7 percentage of cells per cubic millimeter Interval -24.4 to 42.1	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 NK cells; C1D8	-30.1 percentage of cells per cubic millimeter Interval -39.7 to 15.2	—	—	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 NK cells; C2D8	—	7.4 percentage of cells per cubic millimeter Interval -28.1 to 75.9	47.4 percentage of cells per cubic millimeter Interval 22.2 to 55.6	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD4+ Ki67; C1D8	112.8 percentage of cells per cubic millimeter Interval 69.2 to 352.5	—	—	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD8+ Ki67; C2D8	—	66.7 percentage of cells per cubic millimeter Interval -35.2 to 900.0	-40.0 percentage of cells per cubic millimeter Interval -57.0 to 318.3	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD4+; C1D8	-12.5 percentage of cells per cubic millimeter Interval -20.5 to 2.9	—	—	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD4+; C2D1	10.1 percentage of cells per cubic millimeter Interval -15.2 to 26.2	6.1 percentage of cells per cubic millimeter Interval -20.2 to 45.7	9.2 percentage of cells per cubic millimeter Interval -16.6 to 34.9	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD4+; C2D8	—	12.8 percentage of cells per cubic millimeter Interval -6.5 to 63.8	16.1 percentage of cells per cubic millimeter Interval -13.2 to 52.7	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD4+; C3D1	—	-12.3 percentage of cells per cubic millimeter Interval -32.6 to 8.0	23.0 percentage of cells per cubic millimeter Interval 6.3 to 39.9	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD8+; C1D8	-23.3 percentage of cells per cubic millimeter Interval -37.8 to -10.3	—	—	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD8+; C2D1	3.6 percentage of cells per cubic millimeter Interval -30.2 to 23.1	40.4 percentage of cells per cubic millimeter Interval -18.2 to 59.2	10.6 percentage of cells per cubic millimeter Interval -15.6 to 50.6	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 T cells CD8+; C3D1	—	-8.3 percentage of cells per cubic millimeter Interval -24.5 to 7.9	0.6 percentage of cells per cubic millimeter Interval -5.5 to 2.6	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 B cells; C1D8	-29.2 percentage of cells per cubic millimeter Interval -40.6 to -24.7	—	—	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 NK cells; C2D1	-25.8 percentage of cells per cubic millimeter Interval -49.2 to 55.3	31.0 percentage of cells per cubic millimeter Interval -1.1 to 59.6	32.2 percentage of cells per cubic millimeter Interval 14.3 to 56.8	—	—	—
Median Percent Change From Baseline of Cluster of Differentiation 4+ (CD4+), CD8+, B Cells, Natural Killer (NK) Cells, and T-cell Activation With Ki67 NK cells; C3D1	—	25.9 percentage of cells per cubic millimeter Interval -9.6 to 61.4	43.7 percentage of cells per cubic millimeter Interval -26.9 to 77.2	—	—	—

Adverse Events

Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg

Serious events: 1 serious events

Other events: 6 other events

Deaths: 6 deaths

Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg

Serious events: 1 serious events

Other events: 11 other events

Deaths: 8 deaths

Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg

Serious events: 0 serious events

Other events: 3 other events

Deaths: 3 deaths

Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg

Serious events: 1 serious events

Other events: 7 other events

Deaths: 7 deaths

SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg

Serious events: 6 serious events

Other events: 8 other events

Deaths: 8 deaths

STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg

Serious events: 3 serious events

Other events: 9 other events

Deaths: 7 deaths

Serious adverse events

Serious adverse events
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=7 participants at risk Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=11 participants at risk Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 participants at risk Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 participants at risk Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=11 participants at risk Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=10 participants at risk Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Nervous system disorders Transverse sinus thrombosis	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Laryngospasm	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Pulmonary thrombosis	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Ascites	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Colitis	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Constipation	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders Anaemia	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
General disorders Pyrexia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	27.3% 3/11 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Infections and infestations Gastroenteritis rotavirus	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications Fall	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications Femur fracture	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Platelet count decreased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.

Other adverse events

Other adverse events
Measure	Arm A (>= 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=7 participants at risk Participants who weighed \>= 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm A (>= 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=11 participants at risk Participants who weighed \>= 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 20 mg/kg + Tremelimumab 1mg/kg n=3 participants at risk Participants who weighed \< 35 kg were administered durvalumab 20 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	Arm B (< 35 kg): Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=8 participants at risk Participants who weighed \< 35 kg were administered durvalumab 30 mg/kg IV in Cycle 1 followed by durvalumab in combination with tremelimumab 1 mg/kg IV in Cycles 2-5 every 28 days. From Cycle 6 onwards participants were administered durvalumab 20 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	SARCOMA: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=11 participants at risk Participants with osteosarcoma and Ewing sarcoma, rhabdomyosarcoma, non rhabdomyosarcoma soft tissue sarcoma, and other sarcomas were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever occurred first.	STO: Durvalumab 30 mg/kg + Tremelimumab 1mg/kg n=10 participants at risk Participants with solid tumor other (STO) were included in this arm. Participants were administered durvalumab 30 mg/kg IV in combination with tremelimumab 1 mg/kg IV in Cycles 1-4 every 28 days. From Cycle 5 onwards participants were administered durvalumab 30 mg/kg every 28 days until clinical or confirmed disease progression or until any of other discontinuation criterion was met, whichever came occurred first.
Respiratory, thoracic and mediastinal disorders Tachypnoea	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Endocrine disorders Hypothyroidism	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Tumour pain	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Nervous system disorders Amputation stump pain	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Nervous system disorders Anosmia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Nervous system disorders Dysaesthesia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Nervous system disorders Headache	14.3% 1/7 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	36.4% 4/11 • Number of events 5 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	25.0% 2/8 • Number of events 7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	20.0% 2/10 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Nervous system disorders Horner's syndrome	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Nervous system disorders Hypersomnia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Nervous system disorders Hypoaesthesia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Nervous system disorders Neuralgia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Nervous system disorders Peripheral sensory neuropathy	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Eye disorders Eyelid oedema	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Nervous system disorders Presyncope	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Nervous system disorders Retinal migraine	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Nervous system disorders Somnolence	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Psychiatric disorders Anxiety	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Psychiatric disorders Depressed mood	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Psychiatric disorders Insomnia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	27.3% 3/11 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Psychiatric disorders Irritability	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Psychiatric disorders Restlessness	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Renal and urinary disorders Dysuria	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Eye disorders Periorbital oedema	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Renal and urinary disorders Glycosuria	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Renal and urinary disorders Haematuria	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Renal and urinary disorders Leukocyturia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Renal and urinary disorders Proteinuria	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Reproductive system and breast disorders Erectile dysfunction	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Bronchospasm	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Cough	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	25.0% 2/8 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	30.0% 3/10 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Dyspnoea	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	25.0% 2/8 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Epistaxis	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Abdominal pain	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	27.3% 3/11 • Number of events 4 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	27.3% 3/11 • Number of events 4 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Nasal congestion	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Pleural effusion	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Pneumonitis	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinitis allergic	14.3% 1/7 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Rhinorrhoea	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Respiratory, thoracic and mediastinal disorders Wheezing	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Dry skin	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Abdominal pain upper	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Erythema	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Petechiae	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Pruritus	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Rash	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	20.0% 2/10 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Rash maculo-papular	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Skin depigmentation	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Skin and subcutaneous tissue disorders Vitiligo	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Vascular disorders Hot flush	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Vascular disorders Hypertension	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Vascular disorders Superior vena cava syndrome	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Ascites	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Colitis	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Constipation	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 4 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Diarrhoea	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	27.3% 3/11 • Number of events 5 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	20.0% 2/10 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Dysphagia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders Anaemia	28.6% 2/7 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	36.4% 4/11 • Number of events 5 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	30.0% 3/10 • Number of events 4 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Flatulence	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Gastrooesophageal reflux disease	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Nausea	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	63.6% 7/11 • Number of events 10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Odynophagia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Oral pain	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Pancreatitis	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Stomatitis	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Gastrointestinal disorders Vomiting	42.9% 3/7 • Number of events 5 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	37.5% 3/8 • Number of events 6 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	20.0% 2/10 • Number of events 6 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
General disorders Asthenia	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	20.0% 2/10 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
General disorders Chest pain	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders Haemolysis	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
General disorders Complication associated with device	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
General disorders Fatigue	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	20.0% 2/10 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
General disorders Non-cardiac chest pain	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
General disorders Oedema peripheral	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
General disorders Papillitis	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
General disorders Pyrexia	28.6% 2/7 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	25.0% 2/8 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	54.5% 6/11 • Number of events 9 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	40.0% 4/10 • Number of events 5 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Immune system disorders Anaphylactic reaction	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Infections and infestations Bed bug infestation	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Infections and infestations COVID-19	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Infections and infestations Folliculitis	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders Haemolytic anaemia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Infections and infestations Oral candidiasis	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Infections and infestations Oral infection	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Infections and infestations Paronychia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Infections and infestations Periorbital infection	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Infections and infestations Pneumonia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Infections and infestations Rhinitis	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Infections and infestations Upper respiratory tract infection	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	66.7% 2/3 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications Contusion	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders Leukopenia	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 6 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Injury, poisoning and procedural complications Procedural pain	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Alanine aminotransferase increased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	36.4% 4/11 • Number of events 5 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 4 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Amylase increased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Aspartate aminotransferase increased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 4 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Blood alkaline phosphatase increased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Blood bicarbonate decreased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	27.3% 3/11 • Number of events 4 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Blood bilirubin increased	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Blood creatinine increased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Blood lactate dehydrogenase increased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders Lymphopenia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Blood thyroid stimulating hormone increased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Blood urea increased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Blood uric acid increased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations C-reactive protein increased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Electrocardiogram T wave abnormal	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Gamma-glutamyltransferase increased	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	20.0% 2/10 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Haemoglobin decreased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Lipase increased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Lymphocyte count decreased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Neutrophil count decreased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders Neutropenia	14.3% 1/7 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Platelet count decreased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations Weight increased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Investigations White blood cell count decreased	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Decreased appetite	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	25.0% 2/8 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	30.0% 3/10 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Dehydration	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hyperglycaemia	28.6% 2/7 • Number of events 4 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hypermagnesaemia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 4 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hyperphosphataemia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hyperuricaemia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hypoalbuminaemia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Blood and lymphatic system disorders Thrombocytopenia	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 5 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hypoglycaemia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	33.3% 1/3 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hypokalaemia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hypomagnesaemia	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hyponatraemia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Metabolism and nutrition disorders Hypophosphataemia	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Arthralgia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	12.5% 1/8 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Back pain	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Bone pain	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Flank pain	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Muscle spasms	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Ear and labyrinth disorders Vertigo	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal chest pain	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	18.2% 2/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Myositis	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Neck pain	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Osteitis	14.3% 1/7 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Pain in extremity	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 2 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Musculoskeletal and connective tissue disorders Spinal pain	14.3% 1/7 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Embryonal rhabdomyosarcoma	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	9.1% 1/11 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/10 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Pericardial effusion malignant	0.00% 0/7 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/3 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/8 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	0.00% 0/11 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.	10.0% 1/10 • Number of events 1 • From first dose of study treatment up to approximately 4 years (clinical DCO of 20 Apr 2023) The safety analysis set included all participants who received any amount of study treatment.

Additional Information

Global Clinical Lead

AstraZeneca

Phone: 1-877-240-9479

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: OTHER